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| Name | Class |
|---|---|
| Vidatak, LLC | INDUSTRY |
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This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive patient communication solution for communication-impaired patients in the intensive care unit that may help decrease days in delirium, decrease anxiety levels, and reduce sedation exposure which are proximal outcomes known to be associated with decreased mechanical ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The primary goal of this Phase II STTR proposal is to further define user requirements and product specifications and develop a prototype of VidaTalk, a patient-centric, touch pad communication software, to provide mechanically ventilated (MV) patients an evidence-based solution for effectively communicating their needs to care providers and family. A secondary goal is to test the impact of the VidaTalk on clinical outcomes. This study will use mixed methods including observations and interaction with hospitalized patients as they use the VidaTalk tool, surveys and medical record data extraction, product evaluation and brief interview, satisfaction surveys with family members of ICU patients, and focus groups with Registered Nurses.
Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices.
Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical setting.
Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application).
Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale.
Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.
Treatment-induced communication impairment is one of the most common and distressful symptoms to mechanically ventilated intensive care unit (ICU) patients and is associated with anxiety, panic, anger, frustration, sleeplessness, and distress.This Phase II Small Business Technology Transfer Research (STTR) will deliver a comprehensive solution that may help decrease days in delirium, decrease anxiety levels, and reduce sedation exposure which are proximal outcomes known to be associated with decreased mechanical ventilation days, shorter lengths of ICU and hospital stay, and lower healthcare cost. The primary goal of this Phase II STTR proposal is to further define user requirements and product specifications and develop a prototype of VidaTalk (previously TouchTalk), a patient-centric, touch pad communication software, to provide mechanically ventilated (MV) patients an evidence-based solution for effectively communicating their needs to care providers and family. A secondary goal is to test the impact of the VidaTalk on clinical outcomes (e.g., patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care). This study will use mixed methods including observations and interaction with hospitalized patients as they use the VidaTalk communication tool, surveys and medical record data extraction, product evaluation and brief interview, satisfaction survey with family members of ICU patients and focus groups with Registered Nurses. Our Phase I STTR successfully delivered a beta prototype that met technical feasibility criteria; however, additional requirements emerged as a common theme from user testing and market analysis. The current study will meet the identified needs for VidaTalk to operate on android devices, be customizable to patients' unique message needs, use pictures symbols for communication, and be able to route patient requests to providers who are not present at the bedside.
Specific Aim 1 (Preliminary to Clinical Trial). Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices.
Specific Aim 2 (Preliminary to Clinical Trial). Demonstrate usability with iterative user assessment testing in a clinical setting.
Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate notable reductions in patient-reported frustration and communication difficulty, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control.
Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale.
Specific Aim 5. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1- VidaTalk post-extubation | Experimental | Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 and Group 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUWMC (Ohio State University Wexner Medical Center), including discharged patients. Group 1 will use an initial android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices. Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions. |
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| Aim 2 - VidaTalk intubated | Experimental | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app |
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| Aim 3 - VidaTalk tablet app | Experimental | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aim 1 - VidaTalk - post-extubation | Other | Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:
Patients will also be asked to (a) comment on the customization of the app and make suggestions; (b) rate the extent to which they would use the device if they were an ICU patient and unable to speak. Group 1 only: Patients will be asked about their preferences for customizing the VidaTalk app. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale | Aim 3 - Mean item score of daily by patient self report using a single item Likert-type scale from the Ease of Communication Scale (ECS) where scores range from 0 "not hard at all" to 4 "extremely hard" | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Patient Reported Anxiety Score Using Visual Analogue Scale | Aim 3 - Calculated mean of daily measure by patient mark (x) or point on the Visual Analogue Scale for anxiety, a 100 mm vertical line ranging from 0 ("not anxious at all") to 10 ("most anxious I've ever been"). | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
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| Name | Affiliation | Role |
|---|---|---|
| Mary Beth Happ, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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Patients were screened for eligibility by critical care research coordinators and referred to the study coordinator and research assistant for bedside eligibility screening and recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 1- VidaTalk Post-extubation | Aim 1 is a two group iterative design preliminary to clinical trial. Group 1 & 2 will each consist of five previously mechanically ventilated patients who will be recruited from the ICUs at the OSUMC including discharged patients. Group 1 will use an initial android prototype of VidaTalk tablet application to be assessed for functionality (ergonomics, ease of use, ease of learning, simplicity, effectiveness and user interface) and usability on customizable communication, picture symbols, and integration with mobile communication devices. Group 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Group 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2019 |
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| Aim 3 - attention-control | Other | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. |
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| Aim 5-VidaTalk Efficacy in Family caregivers | No Intervention | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| Aim 2 - VidaTalk - intubated | Other | Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS). |
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| Aim 3 - VidaTalk tablet app | Device | Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. |
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| Aim 3 - attention-control with non-VidaTalk tablet | Other | Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
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| Mean Patient Frustration With Communication | Aim 3 - This will be the calculated mean of the daily Communication Frustration scale - a single item scale reported by the patient, ranging from 0 "not frustrating" to 4 "extremely frustrating" | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
| Mean Daily Sedation Exposure | Used in Aim 3 only. Calculation of benzodiazepine and morphine equivalents (for opiates) using hospital conversion charts (pharmacy conversion chart). All benzo IV doses were converted to Lorazepam IV doses. All opioid IV doses were converted to morphine IV doses. All benzo oral doses were converted to Lorazepam oral doses. All opioid oral doses were converted to morphine oral doses. Oral doses were converted to IV equivalents. Summed doses of Lorazepam IV and morphine IV were calculated for each study day for each patient. Doses were converted to milligrams per kilogram based on the patient's body weight. Higher numbers indicate greater sedation and/or opiate exposure. | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU |
| Ease of Communication at Extubation /ICU Discharge | Ease of Communication Scale -10-item likert scale total score ranging from 0-40. Each item is 0-4 likert scale, total score is sum of all items with higher scores indicating greater communication difficulty. | measured at Extubation /ICU Discharge |
| Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score | The Richmond Agitation Sedation Scale, a 10-level observational rating of agitation-sedation motor activity ranging from +4 'combative' to -5 unresponsive, with 0 as calm. Since this is a categorical measure, we compared proportion of patients with RASS in -1 to +1 (calm) range during study days. | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
| Delirium/Coma -Free Days | Aim 3 -Delirium/coma-free days is defined as the number of days alive and free of delirium and coma during the 28-day study period. Delirium will be coded as present when a patient displays both features 1 and 2, and either 3 or 4 of the CAM-ICU (Confusion Assessment Method). Coma is defined as a RASS (Richmond Agitation-Sedation Scale ) assessment score of -4 or -5. | Daily, from enrollment to 28 days post-enrollment |
| Family Satisfaction With Care in the Intensive Care Unit FS-ICU | (Aim3 )The Family Satisfaction with ICU Care (FS-ICU 24R) questionnaire overall satisfaction score is derived from questions 1 through 24 (26 items) and combines two subscale summary scores. The satisfaction with care summary score is derived from the questions numbered 1 through 14 (which consists of 16 questions because question 2 has parts a, b and c). The satisfaction with decision making summary score is derived from questions 15 through 24 (10 questions). All questions are coded as integers from 1 (worst) to 5 (best). Rescale the summary scores from 1 through 5 to 0 through 100 by subtracting 1 from the scores (so they can range from 0 to 4) and then multiplying each score by 25. | One 10 minute survey will be given at patient's ICU discharge or extubation |
| Electronic Visual Analogue Scale-validation Measure | (Aim4) visual analogue touch screen scale via android tablet with REDCap link. Not able to calculate because the touch screen scale was unreliable. Patients often needed assistance with the touch screen cursor for this experimental measure. We determined that pencil and paper analogue scale was superior for this patient population. | Only measured at baseline, order of administration randomized before or after paper version |
| Patient Satisfaction With Care | A 24-item survey with lower scores indicating greater satisfaction with care. | Measured at extubation or discharge from ICU which ever comes first |
| Family Member Anxiety | (Aim 5) Hospital Anxiety and Depression Scale (HADS) Anxiety sub scale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of anxiety. | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge |
| Family Member Depression | (Aim 5). Hospital Anxiety and Depression Scale (HADS-D)- Depression Subscale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of depression symptoms. | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge |
| Post-traumatic Stress Symptoms: Impact of Events Scale-revised (IES-R) | (Aim 5) Impact of Events Scale-revised. The IES-R is a 22-item self-report instrument with three subscales including intrusion (8 items), avoidance (8 items), and hyperarousal (6 items). The respondent is asked to report the degree of distress experienced for each item in the past 7 days. Each item is scored on a five-point Likert scale (0, not at all; 1, rarely; 2, occasionally; 3, fairly often; and 4, often) and total scores range from 0 to 88. Higher scores are representative of greater distress. | 1-month, 3-month, 6-month post-discharge |
| Family Communication Difficulty | Family Communication Survey administered to participant families. Sum of 9-items with each item rating 0 (not at all) to 4 (extremely difficult), resulting in a total summed score from 0 - 36. Higher scores indicate greater difficulty. | baseline and extubation or discharge from the ICU |
| Communication Task Error Rate | Aims 1 & 2 - count of the number of errors recorded by video screen capture for each of 8 communication tasks. Individual patients ranged from 0 to 9 errors, however this measure contains no upper range per task as it is a count of actual observed errors committed by patients. | Measured during 30-60 minute usability testing visit which occurs at study completion. This outcome applies only to Aim 1 & 2 arms. |
| Total Error Rate | Aims 1 & 2 - calculated mean of the total number of errors recorded by video screen capture divided by the number of communication tasks completed (8 maximum) Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Removing abandonments, total number of errors = 25/ 82 tasks = 0.30 error rate. Aim 2 intubated patients. 11 patients completed 69 tasks (18 were abandoned; 1 task was refused). Removing abandonments, total number of errors = 60/ 69 tasks = 0.87error rate. | Measured during 30-60 minute usability testing visit which occurs at study completion |
| Patient Satisfaction With Communication Task Ease | Aims 1 & 2 - a single item from the After Scenario Questionnaire (ASQ) of patient's self rating of satisfaction with the "ease of completing" each of 8 communication tasks on the usability test. Question asked of patients was "Overall, I am satisfied with the ease of completing this task". 1-strongly disagree 7-strongly agree. Higher scores indicated greater satisfaction with the ease of completing the task. | Measured during 30-60 minute usability testing visit which occurs at study completion |
| Observed Task Completion Time (in Seconds) | Aims 1 & 2 - This is the time, measured in seconds, on the screen capture recording beginning with the communication task command to patient completion of the communication task or message to patient completion of each of the 8 communication tasks on the usability test, calculated from the screen capture recordings | Measured during 30-60 minute usability testing visit which occurs at study completion |
| After-Scenario Questionnaire (ASQ) Score | Aims 1 & 2. The After-Scenario Questionnaire (ASQ) is a 3-item likert-type scale used to assess how difficult a user perceived a task in a usability test. Responses range from 1-strongly disagree to 7- strongly agree. Total score is the sum of the 3 items, possible scores range from 3 to 21. Higher scores indicated better outcomes. This was not measured for each task as that was too burdensome for intubated patients. We measured once as an overall rating at the end of the session- 3-item ASQ. | Measured during 30-60 minute usability testing visit which occurs at study completion |
| System Usability Scale (SUS) -Adapted | Aims 1 & 2, System Usability Scale is 13-item likert type scale with item ratings of 1 'strongly agree' to 7 'strongly disagree' to obtain the patient's rating of overall usability of the VidaTalk application, total scores range from 13 to 91 Note: This is different from the standard 10-item SUS that uses a 5-point scale, with scores ranging 0-100. | Measured during 30-60 minute usability testing visit which occurs at study completion |
| Number of Participants That Responded "Yes" to Having Communication Difficulty at Extubation or ICU Discharge | Measured as a single item : Question asked was - "Presence of communication difficulty in the last few days?" with answers being Yes or No | measured at Extubation /ICU Discharge |
| FG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial. Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| FG002 | Nurse Focus Group - PreClinical Trial Phase | ICU nurses were recruited to participate in qualitative focus group interviews regarding their impressions of the VidaTalk tablet app for use with mechanically ventilated patients, their experience (if any) of using the app, and general perspectives about communicating with mechanically ventilated ICU patients. We also elicited suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care. |
| FG003 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative & quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| FG004 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| FG005 | Nurse Focus Group - VidaTalk RCT | ICU Nurses who had experience with using the VidaTalk tablet app with mechanically ventilated patients were recruited to participate in focus group interviews to obtain their perspectives and experience on using the application as well as suggestions for app improvement. Group interviews were conducted by the PI in a hospital conference room away from patient care. |
| FG006 | Aim 5-VidaTalk Efficacy in Family Caregivers - VidaTalk Group | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. VidaTalk (Intervention) Group receives brief introduction, instruction sheet and completes ICU bedside visitation log with dates and times of visits. |
| FG007 | Aim 5 Family Caregiver - Attention Control | Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log. |
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missing data on two patients in Aim 1 who dropped out
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 1- VidaTalk Post-extubation | Preliminary to clinical trial. Grp1+ Grp2 will each consist of five previously mechanically ventilated patients recruited from the ICUs at the OSUWMC. Grp 1 will use an initial android prototype of VidaTalk tablet application assessed for functionality + usability on a series of scripted communication tasks. Grp 2 will use an improved alpha prototype of VidaTalk tablet application version engineered from observations made during Grp 1 sessions. Aim 1 - VidaTalk - post-extubation: Observation of task completion will be made while patients complete messages using the VidaTalk app: Tired, Pain - rating, location, quality, Ask for doctor, Finger writing, Keyboard phrase. Patients will also complete 1-item difficulty rating + 3-item After-Scenario Questionnaire after each task. Patients will rate the extent to which they would use the device if they were an ICU patient unable to speak. Grp 1 only: will be asked their preferences for customizing the app. |
| BG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial. Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| BG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative & quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| BG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| BG004 | Aim 5-VidaTalk Efficacy in Family Caregivers- VidaTalk Group | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
| BG005 | Aim 5 Family Caregiver- Attention Control | Usual care condition for family communication with mechanically ventilated patients. Family caregivers receive tablet instruction sheet (no VidaTalk app). Family caregivers were asked to enter dates and times of visits into ICU bedside visitation log. |
| BG006 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is measured in years, information collected from electronic medical record for patient age. Family age was self-reported. Cumulative age average is calculated for Aim 3 RCT only, n=63 ICU patients. Not on 133 participants. Family participants and pre-RCT patient data are removed. | Mean | Standard Deviation | years |
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| Sex: Female, Male | categorical male, female. Patient data from electronic medical record. Family caregiver self-report. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | NIH ethnicity categories | Count of Participants | Participants |
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| Race (NIH/OMB) | NIH Categories applied | Count of Participants | Participants |
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| Education | dichotomized high school graduate or less; some college | number analyzed differs from overall due to missing data | Count of Participants | Participants | No |
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| severity of illness | Acute Physiology, Age, and Chronic Health Evaluation (APACHE) iii severity of illness scale for critical illness - age, acute physiology and chronic illness weighted scores. Scores range from 0 to 299, with larger scores indicating more severe illness and higher risk of death. Weighted subscales for acute physiology, age and chronic health are summed to determine total score. | not applicable to this arm Total analysis is limited to RCT Aim 3, n=63 patients. Pre-RCT data removed as not applicable. | Mean | Standard Deviation | units on a scale |
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| Intubation Method | Dichotomous - oral intubation or tracheostomy | not applicable to extubated patients and family caregiver arm | Count of Participants | Participants |
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| Physical Restraint | dichotomous yes (presence of wrist restraint) vs. no restraint | Only measured for patients in the RCT, Aim 3 | Count of Participants | Participants |
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| Patient Anxiety | Visual Analogue scale (VAS) anxiety 0-10 scale was used on Aim 3 only. Self report of anxiety using Visual Analog Scale-Anxiety (VAS-A) 0-10 scale on a 100-mm scale was used to measure anxiety. Higher scores indicate greater severity of anxiety. 100 mm scale was divided by 10 to reach the 0-10 scale. | not assessed in preclinical group | Mean | Standard Deviation | units on a scale |
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| Patient Communication Difficulty | Single item rating, patient self-report 0= not at all to 4= extremely difficult | Patient measure only. Not applicable in Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable | Mean | Standard Deviation | units on a scale |
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| Patient Frustration with Communication | single item rating scale, patient self-report. 0= not at all to 4 = extremely frustrating | Data missing on dropouts in Aim 1 and 2. Patient measure only, not applicable to Aim 5 Total mean calculation limited to RCT Aim 3 only, n=63 patients. Pre-RCT data removed as not applicable | Mean | Standard Deviation | units on a scale |
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| Family Caregiver Anxiety | Hospital Anxiety and Depression Scale (HADS) Anxiety sub scale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of anxiety. | not assessed in patient samples, only Aim 5 | Mean | Standard Deviation | units on a scale |
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| Family Caregiver Depression | Hospital Anxiety and Depression Scale (HADS-D)- Depression Subscale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of depression symptoms. | HADS not assessed in patient samples, only Aim 5 | Mean | Standard Deviation | units on a scale |
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| Family Communication Survey | Family Communication Survey is an investigator developed measure. Self-report measure of perceived difficulty communicating with mechanically ventilated patients. This tool contains nine items, and each item is scored on a five-point Likert scale (1, strongly disagree; 2, disagree; 3, not sure; 4, agree; and 5, strongly agree). Total scores range from 9 to 45, and higher scores indicate less perceived communication difficulty. Item 9 score was reversed for a total score. | Measure is for Family caregivers only, Aim 5 | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Daily Patient-reported Communication Difficulty Rating Using Single Item 0-4 Rating Scale | Aim 3 - Mean item score of daily by patient self report using a single item Likert-type scale from the Ease of Communication Scale (ECS) where scores range from 0 "not hard at all" to 4 "extremely hard" | This outcome is only for the clinical trial. Applies only to Aim 3 arms. | Posted | Mean | Standard Deviation | score on a scale | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
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| Secondary | Mean Patient Reported Anxiety Score Using Visual Analogue Scale | Aim 3 - Calculated mean of daily measure by patient mark (x) or point on the Visual Analogue Scale for anxiety, a 100 mm vertical line ranging from 0 ("not anxious at all") to 10 ("most anxious I've ever been"). | This Secondary Outcome is for participants in Aim 3 only. | Posted | Mean | Standard Deviation | score on a scale | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
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| Secondary | Mean Patient Frustration With Communication | Aim 3 - This will be the calculated mean of the daily Communication Frustration scale - a single item scale reported by the patient, ranging from 0 "not frustrating" to 4 "extremely frustrating" | This information is for Aim 3 only. | Posted | Mean | Standard Deviation | units on a scale | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
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| Secondary | Mean Daily Sedation Exposure | Used in Aim 3 only. Calculation of benzodiazepine and morphine equivalents (for opiates) using hospital conversion charts (pharmacy conversion chart). All benzo IV doses were converted to Lorazepam IV doses. All opioid IV doses were converted to morphine IV doses. All benzo oral doses were converted to Lorazepam oral doses. All opioid oral doses were converted to morphine oral doses. Oral doses were converted to IV equivalents. Summed doses of Lorazepam IV and morphine IV were calculated for each study day for each patient. Doses were converted to milligrams per kilogram based on the patient's body weight. Higher numbers indicate greater sedation and/or opiate exposure. | P-values were derived from mixed-effects regression using rank-based sedation exposure | Posted | Mean | Standard Deviation | mg/kg | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU daily in ICU |
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| Secondary | Ease of Communication at Extubation /ICU Discharge | Ease of Communication Scale -10-item likert scale total score ranging from 0-40. Each item is 0-4 likert scale, total score is sum of all items with higher scores indicating greater communication difficulty. | Extubated ICU patients | Posted | Mean | Standard Deviation | score on a scale | measured at Extubation /ICU Discharge |
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| Secondary | Percentage of Patients Scoring in the "Calm" Range During Study Days on Richmond Agitation Sedation Score | The Richmond Agitation Sedation Scale, a 10-level observational rating of agitation-sedation motor activity ranging from +4 'combative' to -5 unresponsive, with 0 as calm. Since this is a categorical measure, we compared proportion of patients with RASS in -1 to +1 (calm) range during study days. | Since this is a categorical measure, we compared percentage of patients with RASS in -1 to +1 (calm) range during study days. | Posted | Number | percentage of participants in calm range | Daily post-randomization until extubation or ICU discharge up to maximum of 28 days in the ICU |
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| Secondary | Delirium/Coma -Free Days | Aim 3 -Delirium/coma-free days is defined as the number of days alive and free of delirium and coma during the 28-day study period. Delirium will be coded as present when a patient displays both features 1 and 2, and either 3 or 4 of the CAM-ICU (Confusion Assessment Method). Coma is defined as a RASS (Richmond Agitation-Sedation Scale ) assessment score of -4 or -5. | Calculated as % days with delirium/total ICU days. | Posted | Number | percent days with delirium/total ICU day | Daily, from enrollment to 28 days post-enrollment |
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| Secondary | Family Satisfaction With Care in the Intensive Care Unit FS-ICU | (Aim3 )The Family Satisfaction with ICU Care (FS-ICU 24R) questionnaire overall satisfaction score is derived from questions 1 through 24 (26 items) and combines two subscale summary scores. The satisfaction with care summary score is derived from the questions numbered 1 through 14 (which consists of 16 questions because question 2 has parts a, b and c). The satisfaction with decision making summary score is derived from questions 15 through 24 (10 questions). All questions are coded as integers from 1 (worst) to 5 (best). Rescale the summary scores from 1 through 5 to 0 through 100 by subtracting 1 from the scores (so they can range from 0 to 4) and then multiplying each score by 25. | Total score on the Family Satisfaction in the Intensive Care Unit Survey (FS-ICU) completed by designated family caregiver-support person. | Posted | Mean | Standard Deviation | score on a scale | One 10 minute survey will be given at patient's ICU discharge or extubation |
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| Secondary | Electronic Visual Analogue Scale-validation Measure | (Aim4) visual analogue touch screen scale via android tablet with REDCap link. Not able to calculate because the touch screen scale was unreliable. Patients often needed assistance with the touch screen cursor for this experimental measure. We determined that pencil and paper analogue scale was superior for this patient population. | Not able to calculate because the touch screen scale was unreliable. Patients often needed assistance with the touch screen cursor for this experimental measure. We determined that pencil and paper analogue scale was superior for this patient population. | Posted | Only measured at baseline, order of administration randomized before or after paper version |
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| Secondary | Patient Satisfaction With Care | A 24-item survey with lower scores indicating greater satisfaction with care. | Patient Satisfaction with Care at extubation /ICU discharge single item likert type scale 1 (very dissatisfied) to 5 (very satisfied) | Posted | Mean | Standard Deviation | units on a scale | Measured at extubation or discharge from ICU which ever comes first |
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| Secondary | Family Member Anxiety | (Aim 5) Hospital Anxiety and Depression Scale (HADS) Anxiety sub scale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of anxiety. | Baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge |
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| Secondary | Family Member Depression | (Aim 5). Hospital Anxiety and Depression Scale (HADS-D)- Depression Subscale including 7 items each scored from 0-3 with total scores ranging from 0 - 21 with higher scores indicating higher levels of depression symptoms. | Aim 5 Family member depression HADS-D subscale | Posted | Mean | Standard Deviation | units on a scale | Baseline, patient extubation or discharge from ICU, 1-month, 3-month, 6-month post-discharge |
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| Secondary | Post-traumatic Stress Symptoms: Impact of Events Scale-revised (IES-R) | (Aim 5) Impact of Events Scale-revised. The IES-R is a 22-item self-report instrument with three subscales including intrusion (8 items), avoidance (8 items), and hyperarousal (6 items). The respondent is asked to report the degree of distress experienced for each item in the past 7 days. Each item is scored on a five-point Likert scale (0, not at all; 1, rarely; 2, occasionally; 3, fairly often; and 4, often) and total scores range from 0 to 88. Higher scores are representative of greater distress. | Impact of events scale median/IQR | Posted | Median | Inter-Quartile Range | units on a scale | 1-month, 3-month, 6-month post-discharge |
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| Secondary | Family Communication Difficulty | Family Communication Survey administered to participant families. Sum of 9-items with each item rating 0 (not at all) to 4 (extremely difficult), resulting in a total summed score from 0 - 36. Higher scores indicate greater difficulty. | Family Communication Survey baseline and extubation or discharge from the ICU | Posted | Mean | Standard Deviation | units on a scale | baseline and extubation or discharge from the ICU |
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| Secondary | Communication Task Error Rate | Aims 1 & 2 - count of the number of errors recorded by video screen capture for each of 8 communication tasks. Individual patients ranged from 0 to 9 errors, however this measure contains no upper range per task as it is a count of actual observed errors committed by patients. | Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Removing abandonments. | Posted | Number | Errors | Measured during 30-60 minute usability testing visit which occurs at study completion. This outcome applies only to Aim 1 & 2 arms. |
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| Secondary | Total Error Rate | Aims 1 & 2 - calculated mean of the total number of errors recorded by video screen capture divided by the number of communication tasks completed (8 maximum) Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Removing abandonments, total number of errors = 25/ 82 tasks = 0.30 error rate. Aim 2 intubated patients. 11 patients completed 69 tasks (18 were abandoned; 1 task was refused). Removing abandonments, total number of errors = 60/ 69 tasks = 0.87error rate. | Aim 1 extubated patients. Using group 1 and group 2 summary data, 11 patients completed 82 tasks (6 were abandoned, 5 of these by one patient). Aim 2 intubated patients. 11 patients completed 69 tasks (18 were abandoned; 1 task was refused). | Posted | Number | error rate | Measured during 30-60 minute usability testing visit which occurs at study completion |
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| Secondary | Patient Satisfaction With Communication Task Ease | Aims 1 & 2 - a single item from the After Scenario Questionnaire (ASQ) of patient's self rating of satisfaction with the "ease of completing" each of 8 communication tasks on the usability test. Question asked of patients was "Overall, I am satisfied with the ease of completing this task". 1-strongly disagree 7-strongly agree. Higher scores indicated greater satisfaction with the ease of completing the task. | Aim 1 Extubated patients - mean Task Ease Rating Aim 2 Intubated patients - mean Task Ease Rating | Posted | Mean | Standard Deviation | score on a scale | Measured during 30-60 minute usability testing visit which occurs at study completion |
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| Secondary | Observed Task Completion Time (in Seconds) | Aims 1 & 2 - This is the time, measured in seconds, on the screen capture recording beginning with the communication task command to patient completion of the communication task or message to patient completion of each of the 8 communication tasks on the usability test, calculated from the screen capture recordings | This is the time, measured in seconds, on the screen capture recording beginning with the communication task command to patient completion of the communication task or message to patient completion of each of the 8 communication tasks on the usability test, calculated from the screen capture recordings | Posted | Mean | Standard Deviation | seconds | Measured during 30-60 minute usability testing visit which occurs at study completion |
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| Secondary | After-Scenario Questionnaire (ASQ) Score | Aims 1 & 2. The After-Scenario Questionnaire (ASQ) is a 3-item likert-type scale used to assess how difficult a user perceived a task in a usability test. Responses range from 1-strongly disagree to 7- strongly agree. Total score is the sum of the 3 items, possible scores range from 3 to 21. Higher scores indicated better outcomes. This was not measured for each task as that was too burdensome for intubated patients. We measured once as an overall rating at the end of the session- 3-item ASQ. | After Scenario Questionnaire is a 3-item patient rating of the usability of the VidaTalk communication application for each communication feature on ease, time, and support information | Posted | Mean | Standard Deviation | score on a scale | Measured during 30-60 minute usability testing visit which occurs at study completion |
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| Secondary | System Usability Scale (SUS) -Adapted | Aims 1 & 2, System Usability Scale is 13-item likert type scale with item ratings of 1 'strongly agree' to 7 'strongly disagree' to obtain the patient's rating of overall usability of the VidaTalk application, total scores range from 13 to 91 Note: This is different from the standard 10-item SUS that uses a 5-point scale, with scores ranging 0-100. | Note: This is different from the standard 10-item SUS that uses a 5-point scale, with scores ranging 0-100. Aim 3 and 5 were not addressed with this question. | Posted | Mean | Standard Deviation | units on a scale | Measured during 30-60 minute usability testing visit which occurs at study completion |
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| Secondary | Number of Participants That Responded "Yes" to Having Communication Difficulty at Extubation or ICU Discharge | Measured as a single item : Question asked was - "Presence of communication difficulty in the last few days?" with answers being Yes or No | Extubated ICU patients | Posted | Count of Participants | Participants | measured at Extubation /ICU Discharge |
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Aims 1 and 2 - 1 hour observation period Aim 3 - 225 total ICU days for VidaTalk patients. 166 total ICU days for control patients. Average of 8 days for the VidaTalk patients and 6 days for control group. Aim 4 - 10 minute observation period Aim 5 - 6 months post ICU discharge
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Aim 1 - VidaTalk Post-Extubation | Specific Aim 1. Develop a commercial prototype of VidaTalk that will include multilingual and customizable messages, compatibility with tablet devices, picture symbols, and integration with mobile communication devices. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | Aim 2 - VidaTalk Intubated | Specific Aim 2. Demonstrate usability with iterative user assessment testing in a clinical setting. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Aim 3 - VidaTalk Tablet App | Specific Aim 3. Test the clinical efficacy of VidaTalk via android application with MV patients by examining qualitative and quantitative endpoints in a clinical setting. Aim 3 hypothesis: MV patients using VidaTalk will demonstrate significant reductions in patient-reported communication difficulty and frustration, anxiety, sedation exposure, delirium/coma-free days, and improved patient and family satisfaction with ICU care compared to MV patients receiving attention-control (i.e., tablets with health education application). | 2 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Aim 3 - Attention Control | Intubated patients who did not receive the VidaTalk Intervention | 0 | 32 | 0 | 32 | 0 | 32 |
| EG004 | Aim 4 | Specific Aim 4. Validation of electronic visual analogue scale, versus current standard paper scale. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Aim 5 - VidaTalk Efficacy in Family Caregivers - VidaTalk Group | Specific Aim 5 a, b and c. Test the effect of the communication tablet (VidaTalk) on psychological symptoms in family caregivers. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG006 | Aim 5 - Family Caregiver Attention Control | Family members of patients who did not receive the VidaTalk Intervention | 0 | 16 | 0 | 16 | 0 | 16 |
| EG007 | Nurse Focus Group - PreClinical Trial Phase | Focus group of ICU nurses on how to implement the VidaTalk Intervention | 0 | 7 | 0 | 7 | 0 | 7 |
| EG008 | Nurse Focus Group - VidaTalk RCT | Focus group of ICU nurses regarding the utility of the VidaTalk Intervention for communication with patients. | 0 | 7 | 0 | 7 | 0 | 7 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Beth Happ, PhD, RN | The Ohio State University | 614-292-8336 | happ.3@osu.edu |
| Oct 15, 2021 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2018 | Oct 15, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D009633 | Nonverbal Communication |
| D016638 | Critical Illness |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS). |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.
Intervention is usability tasks with the VidaTalk app
Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| Aim 2 - VidaTalk Intubated |
Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Intervention for Family Members | Aim 5 - Vida Talk Intervention with Family Members |
| OG005 | Aim-5 Control Group | Aim - 5 Control Group |
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Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability.
Intervention is usability tasks with the VidaTalk app
Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Intervention for Family Members | Aim 5 - VidaTalk Intervention for Family Members |
| OG005 | Aim-5 Control Group | Aim - 5 Control Group |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
| OG005 | Aim-5 Control Group | Aim 5 - Control Group |
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Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Intervention in Family Members | Aim 5 - VidaTalk Intervention in family members |
| OG005 | Aim-5 Control Group | Aim - 5 Control Group |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten (10) intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS). |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG001 | Aim 2 - VidaTalk Intubated | Usability testing preliminary to Clinical Trial (Aim 3). Mechanically Ventilated patients will provide feedback on acceptability, will perform test messages with minimal errors, and will rate VidaTalk an overall average score of 4.5 or higher (Likert-type scale; 1 to 7) on usability questions. Prior to implementing these procedures, the company will perform further iterative design assessments and engineer a Vidatalk tablet application prototype. This prototype will be used with a final group of ten intubated patients receiving mechanical ventilation support to field-test the prototype for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Intervention is usability tasks with the VidaTalk app Aim 2 - VidaTalk - intubated: Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human- |
| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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| OG002 | Aim 3 - VidaTalk Tablet App | Test the clinical efficacy of VidaTalk with MV patients by examining qualitative and quantitative endpoints in a clinical setting. 35 intubated patients (oral endotracheal tube or tracheostomy) will be randomized to the intervention arm and will receive a protocolized instruction in the use of the VidaTalk application including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 min) each day to check user needs and concerns and will review or retrain on message options if needed. Intervention will be receipt of VidaTalk tablet application. Aim 3 - VidaTalk tablet app: Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration. |
| OG003 | Aim 3 - Attention-control | 35 intubated patients (oral endotracheal tube or tracheostomy) will receive the standard of care, which may include primarily writing tools (paper and pen) and, occasionally, picture or alphabet communication charts. Patients randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk application, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. Interventions will be Aim 3 - attention-control with non-VidaTalk tablet. Aim 3 - attention-control with non-VidaTalk tablet: Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet. |
| OG004 | Aim 5-VidaTalk Efficacy in Family Caregivers | Aim 5 will test the preliminary efficacy of VidaTalk compared to attention control (AC) on anxiety and depression symptoms in family caregivers during the ICU stay and post-discharge (1-mos; 3-mos; 6-mos) and PTSD-related symptoms post-discharge both qualitatively and quantitatively. Aim 5.a.) Psychological outcomes (anxiety, depression, and PTSD-related symptoms) between the two groups will be compared at each time point and across time. Aim 5.b.) Family caregivers' perceived communication difficulty will be measured .Aim 5.c.) Family caregivers' experience of communication while they were visiting the patient who received the VidaTalk app in the ICU and their emotional reactions to communication with a patient will be measured. |
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