Trial Outcomes & Findings for The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study (NCT NCT04482036)
NCT ID: NCT04482036
Last Updated: 2023-09-01
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Calculated at 3 months
Results posted on
2023-09-01
Participant Flow
Participant milestones
| Measure |
Dementia Collaborative Care - Patients
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study
Baseline characteristics by cohort
| Measure |
Dementia Collaborative Care - Patients
n=5 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care - Caregivers
n=5 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Patients
n=5 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=5 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Age, Continuous
|
78.2 years
n=99 Participants
|
64.4 years
n=107 Participants
|
78.2 years
n=206 Participants
|
70.6 years
n=7 Participants
|
72.85 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
5 participants
n=7 Participants
|
20 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Calculated at 3 monthsOutcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
n=3 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Calculated at 6 monthsPopulation: The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
|
—
|
2 participants
|
PRIMARY outcome
Timeframe: Calculated at 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Calculated at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Measured at 3 monthsPopulation: 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.
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
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint
|
—
|
4 Participants
|
PRIMARY outcome
Timeframe: Measured at 6 monthsPopulation: 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.
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
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.
|
—
|
2 Participants
|
SECONDARY outcome
Timeframe: Calculated at 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
n=3 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
|
0.33 score on a scale
Interval -4.0 to 7.0
|
1 score on a scale
Interval -7.0 to 8.0
|
SECONDARY outcome
Timeframe: Calculated at 6 monthsPopulation: The study was terminated before the other participants were able to complete this survey at the 6 month time point.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
|
—
|
6 score on a scale
Interval 2.0 to 10.0
|
SECONDARY outcome
Timeframe: Calculated at 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
n=3 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
|
0.33 score on a scale
Interval -4.0 to 7.0
|
4.25 score on a scale
Interval -11.0 to 14.0
|
SECONDARY outcome
Timeframe: Calculated at 6 monthsPopulation: The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
|
—
|
-3.5 score on a scale
Interval -9.0 to 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Calculated at 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
n=3 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
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.
|
-1 score on a scale
Interval -7.0 to 6.0
|
-3.67 score on a scale
Interval -6.0 to -1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Calculated at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
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.
|
—
|
3 score on a scale
Interval 1.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Calculated at 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
n=3 Participants
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=4 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
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.
|
1 score on a scale
Interval -5.0 to 8.0
|
0 score on a scale
Interval -6.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Calculated at 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Control - Dementia Collaborative Care - Caregivers
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=2 Participants
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|
|
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.
|
—
|
-1 score on a scale
Interval -2.0 to 0.0
|
Adverse Events
Dementia Collaborative Care - Patients
Serious events: 3 serious events
Other events: 0 other events
Deaths: 2 deaths
Dementia Collaborative Care - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dementia Collaborative Care Plus BrainCare Notes Application - Patients
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dementia Collaborative Care - Patients
n=5 participants at risk
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care - Caregivers
n=5 participants at risk
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Patients
n=5 participants at risk
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=5 participants at risk
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Hospitalization
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
|
General disorders
Death
|
40.0%
2/5 • Number of events 2 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
Other adverse events
| Measure |
Dementia Collaborative Care - Patients
n=5 participants at risk
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care - Caregivers
n=5 participants at risk
Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
* The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
* Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
* The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
* If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
* The research study team will also notify Dr. Bateman (the person responsible for the research).
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Patients
n=5 participants at risk
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers
n=5 participants at risk
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:
* The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
* The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Pacemaker insertion
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place