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Clinical Trial Summary

This is a single blind, intention-to-treat, randomized controlled trial design to evaluate the feasibility and efficacy of a 12-week, evidence-based, individualized MEMORI Corps program delivered by trained older volunteers (n=80) to community-living PWD/CG dyads (n=240). Eligible PWD/CG dyads will be randomized to receive 12-weeks intervention group (n=120), or 12-week augmented waitlist control group (n=120) followed by 12-weeks of intervention. Eligible volunteers will be randomized to 12 months of MEMORI Corps active duty (n=40) where the participants will be matched to three families over the course of a year, or a 12-month augmented waitlist control group (n=40) followed by opportunity to serve 12 months active duty in MEMORI Corps. Program goals are to address unmet respite care needs for family caregivers, provide persons with dementia meaningful evidence-based activity programming, as well as provide health benefits, meaningful productive engagement, and peer support opportunities for senior volunteers.


Clinical Trial Description

In partnership with the Alzheimer's Association, the investigators propose to evaluate in a NIH Stage III (Real World Efficacy) randomized trial, Making Engagement Meaningful through Organized Routine Interaction (MEMORI) Corps, a novel 12-week activity-based companion care model, to mobilize and equip a critical mass of senior volunteers to deliver individualized, evidence-based activity programming to PWD living at home and offer family CGs needed respite. Synthesizing and adapting prior evidence-based work from the Tailored Activities Program® (a proven activity-based intervention to address functional decline and behavioral symptoms in persons with dementia), Experience Corps® (an inter-generational civic engagement program that engages senior volunteers to work in elementary schools to improve academic outcomes for children and improve health outcomes for the volunteers), and MIND at Home® (a home-based dementia care coordination program delivered by non-clinical care coordinators supported by a clinical team), MEMORI Corps takes a social model of health approach to simultaneously address unmet respite care needs of family CGs, provide PWD structured meaningful activities and social engagement, and provide meaningful engagement and peer support opportunities for senior volunteers-creating potential for a "win-win-win" scenario. This single blind, two-arm, randomized controlled trial will evaluate the feasibility and efficacy of a 12-week, evidence-based, individualized MEMORI Corps program delivered by trained senior volunteers (n=80) to community-living PWD and participant's family caregivers (n=240 dyads). Core intervention components include: (1) detailed initial home-based assessment of interests and preserved abilities of PWD; (2) individualized activity program plans based on interests and abilities; (3) training of volunteers in communication and simplification strategies and use of activity program plans; (4) delivery of activity plans by volunteers to PWD over 12 weeks (8 hours/week) in participant's homes; (5) family CG education on activity plans and ways to utilize respite opportunities; and (6) support of volunteers from a skilled multidisciplinary clinical team. PWD/CG outcomes will be assessed at baseline, 6-, and 12-weeks. Volunteer outcomes will be assessed at baseline, 6- and 12-months (volunteer participation lasts 12 months). Specific aims are to evaluate the: Aim 1: Efficacy of the MEMORI Corps intervention on community-living PWD quality of life and neuropsychiatric symptoms at 6- and 12-weeks (primary endpoint) versus augmented wait-list control. Aim 2: Efficacy of MEMORI Corps intervention on CG subjective and objective burden and depressive symptoms at 6- and 12-weeks (primary endpoint) versus augmented wait-list control. Aim 3: Efficacy of MEMORI Corps intervention on volunteer physical function, cognition, and social and psychological engagement at 6-months and 12-months (primary endpoint) versus augmented wait-list control. Aim 4: Acceptability and feasibility of implementing the MEMORI Corps program from various stakeholder perspectives (PWD, informal CGs, senior volunteers, volunteer coordinators/supervisors). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03896711
Study type Interventional
Source Johns Hopkins University
Contact Quincy Samus, PhD
Phone 4105506493
Email qmiles@jhmi.edu
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date September 29, 2024

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