MEMORI Corps: Activity-based Companion Care for Dementia

NCT03896711 | Completed Results DMC

• 2 other identifiers: IRB00197899R01AG058586
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This project adapts a novel activity-based companion care model, the Making Engagement Meaningful through Organized Routine Interaction (MEMORI) Corps intervention, for a virtual delivery format, and then implements the intervention in a pilot, two-arm, randomized controlled trial to evaluate intervention acceptability, feasibility, and preliminary efficacy versus an augmented waitlist control. MEMORI Corps is a companion care model that provides regular companionship and personalized activities to community-living persons with dementia (PWD) delivered by trained volunteer Companion Guides 55 years of age or older. Program goals are to reduce social isolation and improve health and well-being for PWD, reduce burden and provide support to family CGs, as well as provide health benefits and opportunities for meaningful engagement for older volunteer Companion Guides.

Conditions

Alzheimer Disease; Dementia

Keywords

dementia care; community-based; companion care; activity; caregiver wellbeing; caregiver respite; caregiver support; home-based; volunteer

Outcome Measures

Primary Outcomes (8)

• Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score

  The total score (frequency x severity) of the Neuropsychiatric Inventory (NPI) scale will be used to measure neuropsychiatric and behavioral symptoms. The NPI is a proxy rating of person with dementia's severity, frequency, and distress across 12 types of neuropsychiatric behavior problems. Scores can range from 0-144, with higher score indicating greater neuropsychiatric behavioral burden.

  Baseline - 12 weeks

• Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) Tool

  The total score (sum of all items) for the Quality of life in Alzheimer's Disease (QOL-AD) tool will assess quality of life in the context of Alzheimer's Disease. The QOL-AD has a self-rated and proxy-rated version for persons with dementia, and was specifically developed for use in dementia. Scores can range from 13-52, with higher scores indicating better quality of life.

  Baseline - 12 weeks

• Change in Subjective Caregiver Burden as Assessed by the Zarit Burden Inventory-Short Form

  The total score (sum of items) for the Zarit Burden Inventory-Short Form-12 items (ZBI) will assess subjective caregiver burden. The ZBI short form is a self-rated 12-item measure of caregiver subjective burden rating related to caregiving for persons with dementia. Scores can range from 0-48, with higher scores indicating greater perceived burden.

  Baseline - 12 weeks

• Change in Depressive Symptoms in Caregivers as Assessed by The Patient Health Questionnaire (PHQ) - 8

  The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 8 will assess depressive symptoms severity. The PHQ-8 is a self-rated 8 item measure of caregiver depressive symptoms. Scores can range from 0-24, with higher scores indicating greater depressive symptoms.

  Baseline - 12 weeks

• Change in Perceived Loneliness as Measured by UCLA 3 Loneliness Scale

  Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness.

  Baseline - 12 weeks

• Change in Perceived Loneliness for Caregiver as Measured by UCLA 3 Loneliness Scale

  Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness.

  Baseline - 12 weeks

• Program Satisfaction and Perceived Impact Survey

  55 item likert scale survey assessing program delivery, feasibility, acceptability, perceived program impact. Total score range from 55-253 with higher scores indicating greater satisfaction and perceived feasibility, with higher scores indicating

  12-weeks post intervention

• Change in Perceived Impact of Leisure Activities as Measured by Leisure Activity Participation Impact Scale

  11 item scale measuring the subjective impact of leisure activity participation on several areas of life and emotional well-being. Scores range from 11-55 with higher scores indicating more beneficial subjective impact of leisure activities

  Baseline - 12 weeks

Secondary Outcomes (2)

• Change in Caregiver Time Spent Helping Person Living With Dementia

  Baseline - 12 weeks

• Change in Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8

  Baseline -12 weeks

Study Arms (2)

Active Intervention

EXPERIMENTAL

Intervention arm with MEMORI Corps program

Behavioral: MEMORI Corps program

Control

OTHER

Augmented waitlist control.

Other: Augmented Waitlist Control

Interventions

Augmented Waitlist Control OTHER

Participants living with dementia/caregivers will continue any services and supports already engaged with, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"), a Resource Guide (ie.,local, regional and national resources), and check-in calls to answer any questions about the materials. Waitlist are offered full intervention after waitlist period. Volunteers randomized to waitlist control continue usual activities (volunteer or other), and resource a resource guide on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to volunteering opportunities, and check-in calls to answer questions and maintain engagement. Waitlist dyads will be followed at specified intervals by the research team and then offered an opportunity for participation in the intervention arm.

Control

MEMORI Corps program BEHAVIORAL

MEMORI Corps program: Virtual activity-based companion care program. Delivered by trained volunteers 55 years and older, supported by a clinical team, over a 12-week intervention period (up to 5 hours per week, one or more days per week) for each person with dementia/family caregiver dyad. Primary roles of the volunteers are to provide socialization, companionship, and a personalized activity program that focuses on meaningful, engaging and enjoyable activities that match the participant's abilities and interests. Delivered virtually by Zoom.

Active Intervention

Eligibility Criteria

• Age: 18 Years - 115 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with dementia and informal caregiver (PWD/CG) must both meet eligibility criteria. These criteria are designed to reduce PWD/CG attrition and ensure safety of PWD, CG, and volunteers.
• PWD are eligible if:
• English speaking;
• Have an established physician clinical diagnosis of dementia (any stage) and confirmed with Informant Questionnaire on Cognitive Decline in the. Elderly (IQCODE) cut off \>=52 ,
• Are able to participate in at least 4 basic Activities of Daily Living (out of 11),
• Have not received formal (i.e., in-home companion care, or adult day center) activity-focused care services in the past 4 weeks,
• Living at home in all counties in Maryland and Baltimore City,
• Have a co-residing informal caregiver willing to participate as study partner, and 30 years old or older.
• CG are eligible if:
• English speaking,
• years of age or older (male or female),
• Deemed to be a reliable informal caregiver (not paid for caregiving of PWD) who knows the PWD well,
• Co-residing with the PWD, and
• Relied on by the PWD for assistance in activities of daily living (instrumental or basic).
• Volunteers (i.e. "Companion Guides") are eligible if:

You may not qualify if:

• PWD are excluded if:
• Deemed to be in a crisis/unsafe situation at baseline,
• Planned transition from home in less than 6 months,
• At end-stage disease (e.g. bed-bound and non-communicative, or hospice),
• Currently enrolled in a dementia related clinical trial, or
• Deemed to have severe behavioral symptoms so severe that participation in this study is unsafe (e.g., are placing self or others at harm).
• CGs are excluded if:
• Do not plan to be co-residing with the PWD in the next 6 months, or
• Currently involved in a behavioral/educational clinical trial.
• Volunteers are excluded:
• Planning on moving from the area in the next 12 months,
• Unable to provide informed consent, and
• Report having an existing cognitive disorder diagnosis by a health provider (e.g., Mild Cognitive Impairment, Alzheimer's disease or other type of dementia).

Sponsors & Collaborators

• Johns Hopkins University: lead
• Alzheimer's Association: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Quincy Samus, Professor
• Organization: Johns Hopkins University

qmiles@jhmi.edu

4105506493

Study Officials

• Quincy Samus, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind, pilot, randomized controlled trial where outcome assessors are masked to treatment arm allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Activity-based companion care program. MEMORI Corps is a companion care model that provides regular companionship and personalized activities to community-living persons with dementia (PWD) delivered by trained volunteer Companion Guides 55 years of age or older. Core intervention components include: (1) detailed virtual assessment of health, well-being, and interests of PWD; (2) personalized activity plans; (3) specialized training of volunteer Companion Guides in virtual program delivery; (4) regular companionship and personalized activities delivered to PWD over 12 weeks; (5) family caregiver education on activity plans and ways to utilize respite opportunities; and (6) multidisciplinary expert support of volunteer companion guides. The goals of the program are to reduce social isolation and improve health and well-being for PWD, reduce burden and support family CGs, and to provide health benefits and meaningful engagement for older volunteer Companion Guides.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2022
• Primary Completion: August 12, 2024
• Study Completion: May 31, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)