The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alzheimer Disease
- Mild Cognitive Impairment
- Mild Memory Disturbance
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Investigator, Outcomes Assessor)Masking Description: The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 120 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04482036
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Principal Investigator: Daniel R Bateman, MD Indiana University
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