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

Indiana University

Status: Terminated

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Mild Memory Disturbance

Treatments: Other: Standard Assessments; Other: Mobile Phone Application Assessments

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04482036

1907055854

1K23AG059914-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Dementia Collaborative Care

Placebo Comparator group

Description:

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).

Treatment:

Other: Standard Assessments

Dementia Collaborative Care Plus BrainCare Notes Application

Active Comparator group

Description:

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.

Treatment:

Other: Standard Assessments

Other: Mobile Phone Application Assessments