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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD098328-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient/caregivers to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-to-face arm | Active Comparator | Standard face-to-face burn care. |
|
| TOBI arm | Experimental | A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. TOBI is synced with a portal used by providers, as an adjunct to standard therapy. This burn app provides education through frequently asked questions, instructional burn dressing change videos in addition to direct communication between patient and burn expert through store-and-forward pictures and videoconferencing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Face-to-face burn care | Procedure | If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Agree to Participate in the Study | Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study. | At enrollment |
| Number of Participants Retained in the Study Over Time | Looking at the number of participants retained in the study versus those lost to attrition | From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment). |
| Wound Care Treatment Adherence | Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below. | Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury |
| Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed. | Assessed weekly until burn wound was healed, up to 35 days |
| Number of Times Problems With Technology Happened in the TOBI Condition | Looking at the number of times providers or participants experienced and reported technological problems with TOBI | Assessed weekly until burn wound was healed, up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Until Wound is Healed | Looking at the number of days it takes for wound to heal following burn injury in both conditions | Measured during the treatment phase (2-4 weeks) |
| Number of Unscheduled ED or Clinic Visits |
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Inclusion criteria:
Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Parents/caregivers *and* children were considered enrolled in the study as a dyad, although most of the outcomes were reported by the parent instead of the child. Since demographic data was collected on both the caregiver and the child, the Total Started number is 130 (65 caregivers AND 65 children) as there were 65 dyads enrolled.
Burn patients were recruited from burn clinic and the inpatient hospital setting to participate a study comparing face to face outpatient wound care to virtual wound care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Face-to-face Arm | Standard face-to-face burn care. Face-to-face burn care: If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed. |
| FG001 | TOBI Arm | A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Face-to-face Arm | Standard face-to-face burn care. Face-to-face burn care: If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers. |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Agree to Participate in the Study | Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study. | This includes caregivers and their children. | Posted | Number | participants | At enrollment |
|
For each child participant dyad, adverse event data was only collected on the child participant up to 46 days after burn wound injury.
Adult participants of the dyad were not monitored for adverse events as they did not have burn injuries and are not reported here.
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Face-to-face Arm | Standard face-to-face burn care. Face-to-face burn care: If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unscheduled visit to the ED or Clinic | Skin and subcutaneous tissue disorders | Systematic Assessment | In either arm, we tracked the number of unscheduled or unplanned patient visits to the ED or clinic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron P. Lesher | Medical University of South Carolina | 843-408-6782 | leshera@musc.edu |
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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 | Jul 1, 2023 | Feb 26, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | Dec 21, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| Telemedicine enhanced burn care | Procedure | Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency. |
|
Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
| Measured during the treatment phase (2-4 weeks) |
| Number of Wound Complications | Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy). | Measured during the treatment phase (2-4 weeks) |
| Patient-reported Pain Scores | Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below. | Measured during the treatment phase (week 1 clinic visit) |
| Caregiver's Perception of Child's Pain Scores | Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below. | Measured during the treatment phase (week 1 clinic visit) |
| Attitudes Towards Technology and Telemedicine Questionnaire | Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine. | Measured at baseline and 1-month follow-up |
| Perception of Healthcare Access | Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access. | Measured at baseline and 1-month follow-up |
| Positive And Negative Affect Schedule (PANAS) Scores | Looking at the group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). The means of the positive and negative scores for PANAS are reported below along with standard deviations. The scores range between 10-50, with higher scores = higher levels of affect (both positive and negative). For positive affect, a higher score is a better outcome and for negative affect, a lower score is a better outcome. Scores are reported for baseline and 1 month after burn wound healing. | Measured at baseline/enrollment and 1-month follow-up. |
| Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw scores on the 8 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 37.1-81.1. T scores are interpreted as follows: <55 (none to slight depression), 55-59.9 (mild depression), 60-69.9 (moderate depression), >70 (severe depression). T scores and standard error are reported below. | Measured at baseline and 1-month follow-up |
| Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. T scores are interpreted as follows: <55 (none to slight anxiety), 55-59.9 (mild anxiety), 60-69.9 (moderate anxiety), >70 (severe anxiety). T scores and standard error are reported below. | Measured at baseline and 1-month follow-up |
| Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-General Self Efficacy questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 8 to 40 with higher scores indicating greater self efficacy. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 22.72-64.98. A T-score value of 55 indicated that the respondent has greater self-efficacy for managing emotions. Higher scores indicating more self efficacy and lower scores with less self efficacy. T scores and standard error are reported below. | Measured at baseline only |
| Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Self-Efficacy Managing emotions questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 4-20 with higher scores indicating greater severity of anxiety. The raw scores on the 4 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. A T-score of 55 and greater indicates that the respondent has greater self efficacy and ability to manage their emotions regarding disease. A higher score than 55 indicates even more self efficacy and lower score, less. T scores and standard error are reported below. | Measured at baseline only |
| Peritraumatic Distress Inventory (PDI) Sores | Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury. | Measured at baseline only |
| Perceived Stress Scale (PSS) Scores | Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. | Measured at 1-month follow-up only |
| Posttraumatic Growth Inventory (PTGI) Scores | Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth. | Measured at 1-month follow-up only |
| Client Satisfaction Questionnaire-8 (CSQ-8) Scores | Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction. | Measured at 1-month follow-up only |
| mHealth App Usability Questionnaire (MAUQ) Scores | Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall score equivalent to higher usability of the app. The average scores and standard deviation are reported below for the TOBI group. | Measured at 1-month follow-up only |
| Total Number of Face-to-face Visits | Looking at the total number of face-to-face visits | Treatment phase (weeks 2-4) |
| Total Number of TOBI Visits | Looking at the total number of TOBI visits | Treatment phase (weeks 2-4) |
| Total Travel Time | Looking at the total travel time in each condition as reported by the caregiver. | From enrollment through treatment phase (weeks 1-4) |
| Direct Cost to Patient/Caregiver | Looking at the direct cost to patient/caregiver as reported by caregiver | From enrollment through treatment phase (weeks 1-4) |
| Time to Return to Work | Looking at the average time it took patient/caregiver to return to work after burn wound injury. | From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up. |
| TOBI Arm |
A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. TOBI is synced with a portal used by providers, as an adjunct to standard therapy. This burn app provides education through frequently asked questions, instructional burn dressing change videos in addition to direct communication between patient and burn expert through store-and-forward pictures and videoconferencing. Telemedicine enhanced burn care: Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers. | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Parents/caregivers and patients were considered to be enrolled so baseline characteristics will be listed for both patients and their caregivers. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. |
|
|
| Primary | Number of Participants Retained in the Study Over Time | Looking at the number of participants retained in the study versus those lost to attrition | Parents/caregivers and patients were considered to be enrolled together as a dyad, but are reported here as caregiver and patient. | Posted | Number | participants | From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment). |
|
|
|
| Primary | Wound Care Treatment Adherence | Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below. | Posted | Mean | Standard Deviation | percentage of wound care adherence | Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury |
|
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| Primary | Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed. | Posted | Count of Participants | Participants | Assessed weekly until burn wound was healed, up to 35 days |
|
|
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| Primary | Number of Times Problems With Technology Happened in the TOBI Condition | Looking at the number of times providers or participants experienced and reported technological problems with TOBI | Only participants in the TOBI arm were evaluated for issues with technology as the face to face group did not interact with technology. | Posted | Number | number of technological problems | Assessed weekly until burn wound was healed, up to 35 days |
|
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| Secondary | Number of Days Until Wound is Healed | Looking at the number of days it takes for wound to heal following burn injury in both conditions | Posted | Mean | Standard Deviation | days to wound healed | Measured during the treatment phase (2-4 weeks) |
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| Secondary | Number of Unscheduled ED or Clinic Visits | Looking at the number of times participants had unscheduled visits (in the ED or the clinic) | Posted | Number | number of unscheduled ED/clinic visits | Measured during the treatment phase (2-4 weeks) |
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| Secondary | Number of Wound Complications | Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy). | Posted | Number | number of wound complications | Measured during the treatment phase (2-4 weeks) |
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| Secondary | Patient-reported Pain Scores | Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below. | Posted | Mean | Standard Deviation | units on a scale | Measured during the treatment phase (week 1 clinic visit) |
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| Secondary | Caregiver's Perception of Child's Pain Scores | Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below. | Posted | Mean | Standard Deviation | score on a scale | Measured during the treatment phase (week 1 clinic visit) |
|
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| Secondary | Attitudes Towards Technology and Telemedicine Questionnaire | Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and 1-month follow-up |
|
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| Secondary | Perception of Healthcare Access | Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline and 1-month follow-up |
|
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| Secondary | Positive And Negative Affect Schedule (PANAS) Scores | Looking at the group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). The means of the positive and negative scores for PANAS are reported below along with standard deviations. The scores range between 10-50, with higher scores = higher levels of affect (both positive and negative). For positive affect, a higher score is a better outcome and for negative affect, a lower score is a better outcome. Scores are reported for baseline and 1 month after burn wound healing. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline/enrollment and 1-month follow-up. |
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| Secondary | Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw scores on the 8 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 37.1-81.1. T scores are interpreted as follows: <55 (none to slight depression), 55-59.9 (mild depression), 60-69.9 (moderate depression), >70 (severe depression). T scores and standard error are reported below. | Posted | Mean | Standard Error | T-score | Measured at baseline and 1-month follow-up |
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| Secondary | Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. T scores are interpreted as follows: <55 (none to slight anxiety), 55-59.9 (mild anxiety), 60-69.9 (moderate anxiety), >70 (severe anxiety). T scores and standard error are reported below. | Posted | Mean | Standard Error | T-score | Measured at baseline and 1-month follow-up |
|
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| Secondary | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-General Self Efficacy questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 8 to 40 with higher scores indicating greater self efficacy. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 22.72-64.98. A T-score value of 55 indicated that the respondent has greater self-efficacy for managing emotions. Higher scores indicating more self efficacy and lower scores with less self efficacy. T scores and standard error are reported below. | Posted | Mean | Standard Error | T-score | Measured at baseline only |
|
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| Secondary | Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Self-Efficacy Managing emotions questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 4-20 with higher scores indicating greater severity of anxiety. The raw scores on the 4 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. A T-score of 55 and greater indicates that the respondent has greater self efficacy and ability to manage their emotions regarding disease. A higher score than 55 indicates even more self efficacy and lower score, less. T scores and standard error are reported below. | Posted | Mean | Standard Error | T-score | Measured at baseline only |
|
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| Secondary | Peritraumatic Distress Inventory (PDI) Sores | Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury. | Posted | Mean | Standard Deviation | units on a scale | Measured at baseline only |
|
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| Secondary | Perceived Stress Scale (PSS) Scores | Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. | Posted | Mean | Standard Deviation | units on a scale | Measured at 1-month follow-up only |
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| Secondary | Posttraumatic Growth Inventory (PTGI) Scores | Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth. | Posted | Mean | Standard Deviation | units on a scale | Measured at 1-month follow-up only |
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| Secondary | Client Satisfaction Questionnaire-8 (CSQ-8) Scores | Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction. | Posted | Mean | Standard Deviation | units on a scale | Measured at 1-month follow-up only |
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| Secondary | mHealth App Usability Questionnaire (MAUQ) Scores | Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall score equivalent to higher usability of the app. The average scores and standard deviation are reported below for the TOBI group. | The face-to-face arm did not use the TOBI app at all, therefore they did not take the MAUQ to rate the app. | Posted | Mean | Standard Deviation | units on a scale | Measured at 1-month follow-up only |
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| Secondary | Total Number of Face-to-face Visits | Looking at the total number of face-to-face visits | Posted | Mean | Standard Deviation | number of visits | Treatment phase (weeks 2-4) |
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| Secondary | Total Number of TOBI Visits | Looking at the total number of TOBI visits | This outcome only pertains to the TOBI arm as the face-to-face arm did not have any TOBI visits. | Posted | Mean | Standard Deviation | number of visits | Treatment phase (weeks 2-4) |
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| Secondary | Total Travel Time | Looking at the total travel time in each condition as reported by the caregiver. | Posted | Mean | Standard Deviation | hours | From enrollment through treatment phase (weeks 1-4) |
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| Secondary | Direct Cost to Patient/Caregiver | Looking at the direct cost to patient/caregiver as reported by caregiver | Posted | Mean | Standard Deviation | dollars | From enrollment through treatment phase (weeks 1-4) |
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| Secondary | Time to Return to Work | Looking at the average time it took patient/caregiver to return to work after burn wound injury. | Posted | Mean | Standard Deviation | days | From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up. |
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| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | TOBI Arm | A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. The app was designed to bring expert wound care directly to the patient's home to address barriers to healthcare, including high cost burden and time commitment (e.g., geographic limitations, transportation to burn centers, parking, lodging, meals, time away from school and work), particularly for patients/families in rural and medically underserved communities. | 0 | 32 | 0 | 32 | 2 | 32 |
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Not provided
Not provided
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 month follow up Positive Affect |
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| 1 month follow up Negative Affect |
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