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

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

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Mild Memory Disturbance
• Intervention / Treatment: Other: Standard Assessments; Other: Mobile Phone Application Assessments

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Dementia Collaborative Care; 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; 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.
Active Comparator: Dementia Collaborative Care Plus BrainCare Notes Application; Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following: 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: 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.; Other: 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.; Other Names: BrainCare Notes app

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.	Calculated at 3 months
Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.	Calculated at 6 months
Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.	The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.	Calculated at 3 months
Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.	The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.	Calculated at 6 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Daniel R Bateman, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): October 4, 2021
• Study Completion (Actual): October 4, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Mobile Health; Caregiver Burden; Caregiver Stress; mHealth; Behavioral Symptoms; Behavioral and Psychological Symptoms of Dementia; Neuropsychiatric Symptoms; Psychological Symptoms; Patient Distress; Mobile Phone Application
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 1907055854; 1K23AG059914-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No