The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study
- Conditions
- Mild Memory DisturbanceMild Cognitive ImpairmentAlzheimer Disease
- Interventions
- Other: Standard AssessmentsOther: Mobile Phone Application Assessments
- Registration Number
- NCT04482036
- Lead Sponsor
- Indiana University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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The patient:
- Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a Healthy Aging Brain Center, Eskenazi Health patient
- Community dwelling
- Has a legally authorized representative when they lack capacity to consent
-
The caregiver:
- 18 or older
- No visual impairment
- Community dwelling
- Reports seeing patient most days of the week
-
The patient:
- History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)
- Participating in another study
- The potential participant with a diagnosis of either aMCI or AD communicates observable dissent.
-
The caregiver:
- History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)
- Participating in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dementia Collaborative Care Standard Assessments 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). Dementia Collaborative Care Plus BrainCare Notes Application Standard Assessments 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. Dementia Collaborative Care Plus BrainCare Notes Application Mobile Phone Application Assessments 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.
- Primary Outcome Measures
Name Time Method Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months Calculated at 6 months Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint Measured at 3 months 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
Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint. Measured at 6 months 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
Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months Calculated at 3 months Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months Calculated 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.
Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months Calculated 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.
- Secondary Outcome Measures
Name Time Method Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. Calculated at 3 months 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 of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. Calculated at 6 months 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 of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline. Calculated at 3 months 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 of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline. Calculated at 6 months 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.
Trial Locations
- Locations (1)
Eskenazi Health
🇺🇸Indianapolis, Indiana, United States