Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease
  • Dementia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Activity-based companion care program. Delivered by trained senior volunteers, supported by a clinical team, over a 12-week intervention period (8 hours per week, 2 or 3 days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide in-home supervision, peer-to-peer companionship, and a evidence-based individualized activity program that focuses on meaningful, engaging and enjoyable activities that match PWD abilities and interests.Masking: Single (Outcomes Assessor)Masking Description: Single blind randomized controlled trial where outcome assessors are masked to treatment arm allocation.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 115 years
Gender
Both males and females

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 eq...

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).

Tracking Information

NCT #
NCT03896711
Collaborators
  • Alzheimer's Association
  • National Institute on Aging (NIA)
Investigators
Principal Investigator: Quincy Samus, PhD Johns Hopkins University