The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic Mild Cognitive Impairment and Alzheimer's Disease (MOMENT) Study: A Randomized Controlled Trial

Conditions
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Alzheimer Disease, Mild Memory Disturbance, Mild Cognitive Impairment

Intervention / Treatment
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* Other: Mobile Phone Application Assessments
* Other: Standard Assessments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dementia Collaborative Care<br>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). | Other: Standard Assessments<br>* 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.<br>|
| Active Comparator: Dementia Collaborative Care Plus BrainCare Notes Application<br>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. | Other: Mobile Phone Application Assessments<br>* 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.<br>* Other names: BrainCare Notes app;Other: Standard Assessments<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Measured at 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Distress, Caregiver Burden, Caregiver Stress, Mobile Phone Application, Psychological Symptoms, Behavioral Symptoms, Behavioral and Psychological Symptoms of Dementia, Neuropsychiatric Symptoms, mHealth, Mobile Health