Clinical trial NCT04482036: The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Mild Memory Disturbance
Mild Cognitive Impairment
Keywords: Patient Distress
Caregiver Burden
Caregiver Stress
Mobile Phone Application
Psychological Symptoms
Behavioral Symptoms
Behavioral and Psychological Symptoms of Dementia
Neuropsychiatric Symptoms
mHealth
Mobile Health
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months
timeFrame: Calculated at 3 months
measure: Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
timeFrame: Calculated at 6 months
measure: Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months
timeFrame: Calculated at 3 months
measure: Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months
timeFrame: Calculated at 6 months
measure: Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint
timeFrame: Measured at 3 months
measure: Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.
timeFrame: Measured at 6 months
Secondary outcomes:
measure: Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
timeFrame: Calculated at 3 months
measure: Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
timeFrame: Calculated at 6 months
measure: Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
timeFrame: Calculated at 3 months
measure: Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
timeFrame: Calculated at 6 months
Other outcomes:
measure: 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.
timeFrame: Calculated at 3 months
measure: 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.
timeFrame: Calculated at 6 months
measure: 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.
timeFrame: Calculated at 3 months
measure: 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.
timeFrame: Calculated at 6 months
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Daniel R Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References: