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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG059914-01A1 | U.S. NIH Grant/Contract | View source |
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The Principle Investigator changed careers and relinquished their NIA funded career development award, which funded the MOMENT Study. Career development awards are not transferable. Thus, the study was terminated prematurely.
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimer's disease through a smartphone mobile application. The investigators believe that monitoring these symptoms and having a tool, like a mobile application, can provide quicker accessibility to the patient's clinical care team, which could improve care for patients and caregivers.
These types of symptoms found in patients with mild memory problems or Alzheimer's disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses. Examples of psychological and behavioral symptoms are depression, anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can lead to greater use of healthcare services.
As a part of this research study the patient and caregiver will undergo randomization, "like flipping a coin", to assign the patient and caregiver to one of two research study groups. The patient and the partnered caregiver will join the same group. The group will either receive: 1) three in-person assessments on symptoms and behaviors that the patient may experience and a mobile application that will send surveys to the caregiver in order to rate the presence, severity and stress caused by these symptoms and behaviors; or 2) three in-person assessments on symptoms and behaviors that the patient may experience and no mobile application. The outcomes of these surveys and assessments will then be shared with the patient's clinical team.
If the caregiver is assigned to the group that receives the mobile application they will receive the surveys either weekly or monthly. After each month of completing the surveys, the frequency will change. Depending on feedback from the first 10 participants, the investigators may modify the survey rate to happen more than weekly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia Collaborative Care | Placebo Comparator | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
|
|
| Dementia Collaborative Care Plus BrainCare Notes Application | Active Comparator | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Phone Application Assessments | Other | The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months | Calculated at 3 months | |
| Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months | Calculated at 6 months | |
| Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application. | Calculated at 3 months |
| Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application. | Calculated at 6 months |
| Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint | The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 | Measured at 3 months |
| Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint. | The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress. |
Inclusion Criteria:
The patient:
The caregiver:
Exclusion Criteria:
The patient:
The caregiver:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Bateman, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dementia Collaborative Care - Patients | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| 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 | May 20, 2021 |
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The study design includes six 1-month periods. Those in the intervention group will be nested in a 2 x 6 cross-over design in which they will be randomly assigned to start with 1 of 2 schedules of Ecological Momentary Assessment (EMA) surveillance frequency (1) weekly or (2) monthly. The intervention participants will then cross-over at the end of each and every month to the other surveillance frequency condition, over a 6-month time horizon.
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The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.
|
|
| Standard Assessments | Other | The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
|
| Measured at 6 months |
| Calculated at 3 months |
| Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. | Calculated at 6 months |
| Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. | Calculated at 3 months |
| Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. | Calculated at 6 months |
| Calculated at 3 months |
| Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress. | Calculated at 6 months |
| Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. | Calculated at 3 months |
| Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. | Calculated at 6 months |
| FG001 | Dementia Collaborative Care - Caregivers | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| FG002 | Dementia Collaborative Care Plus BrainCare Notes Application - Patients | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| FG003 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dementia Collaborative Care - Patients | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| BG001 | Dementia Collaborative Care - Caregivers | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| BG002 | Dementia Collaborative Care Plus BrainCare Notes Application - Patients | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| BG003 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months | Posted | Count of Participants | Participants | Calculated at 3 months |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months | The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point. | Posted | Number | participants | Calculated at 6 months |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application. | This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only 4 randomized participants who reached this time point before the study was terminated. | Posted | Count of Participants | Participants | Calculated at 3 months |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months | Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application. | This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only two randomized participants that reached the 6 month time point before the study was terminated. | Posted | Count of Participants | Participants | Calculated at 6 months |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint | The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 | This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before the other participant reached the 3 month time point. | Posted | Count of Participants | Participants | Measured at 3 months |
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint. | The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5 | This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point. | Posted | Count of Participants | Participants | Measured at 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. | There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. The study was terminated before the other participant reached the 3 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 3 months |
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| Secondary | Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity. | The study was terminated before the other participants were able to complete this survey at the 6 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 6 months |
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| Secondary | Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. | There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before reaching this time point. The study was terminated before the other participant reached the 3 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 3 months |
| ||||||||||||||||||||||||||||||
| Secondary | Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia. The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity. | The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 6 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress. | There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected because the study was terminated. The study was terminated before the other participant reached the 3 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 3 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress. | The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected. | Posted | Mean | Full Range | score on a scale | Calculated at 6 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. | There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before the time point was reached. The study was terminated before the other participant reached the 3 month time point. | Posted | Mean | Full Range | score on a scale | Calculated at 3 months |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. | The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden. | The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected. | Posted | Mean | Full Range | score on a scale | Calculated at 6 months |
|
6 months
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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 | Dementia Collaborative Care - Patients | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 2 | 5 | 3 | 5 | 0 | 5 |
| EG001 | Dementia Collaborative Care - Caregivers | Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Dementia Collaborative Care Plus BrainCare Notes Application - Patients | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG003 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. | 0 | 5 | 0 | 5 | 0 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment | Bilateral pulmonary embolism |
| |
| Death | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pacemaker insertion | Cardiac disorders | Systematic Assessment |
|
The study was terminated [The Principle Investigator changed careers and relinquished their NIA funded career development award, which funded the MOMENT Study. Career development awards are not transferable. Thus, the study was terminated prematurely.]
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Broughton | Eskenazi Health | 317-903-6276 | jessica.broughton@eskenazihealth.edu |
| Feb 10, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D000084802 | Caregiver Burden |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| ID | Term |
|---|---|
| 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 |
| D003072 | Cognition Disorders |
| D013315 | Stress, Psychological |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.
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| OG001 | Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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| OG001 | Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers | Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe. The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team. Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires. |
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