Alzheimer Disease Clinical Trial
Official title:
MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers
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.
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). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |