NCT04482036

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Mild Memory Disturbance
• Mild Cognitive Impairment

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2020-10-23
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2020-07-22
• Last updated: 2023-09-01
• Results posted: 2023-09-01

Locations

1 site across 1 country: United States