MEMORI Corps: Activity-based Companion Care for Dementia (MEMORI Corps)

MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: MEMORI Corps program; Other: Augmented Waitlist Control

Detailed Description

This project adapts a novel activity-based companion care model (MEMORI Corps) for community-living persons with dementia 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. 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.

The target group is 60 dyads (persons living with dementia and their informal co-residing caregiver) and 36 companion guides (health volunteer 55 years of age and older). Participants are randomized 1:1 either to the intervention or waitlist control group. Waitlist participants are offered the opportunity for cross-over into active intervention group. PWD/CG outcomes will be assessed at Baseline, 6-, and 12-weeks (PWD/CG participation lasts 12 weeks). Volunteer Companion Guide outcomes will be assessed at baseline, 6-, and 12-months.

This model program could serve as an important new advancement for community-based long term care for PWD that addresses unmet patient- and family-centered needs through civic engagement of seniors. It could also serve as an intervention for dementia risk-reduction and brain health if found to be efficacious.

Specific aims are to:

Aim 1: Adapt and refine the MEMORI Corps intervention for a virtual delivery format using iterative user-centered design principles and multiple stakeholder input.

Aim 2: Conduct a pilot, two-arm, randomized controlled trial to evaluate acceptability, feasibility, safety, and preliminary efficacy of the MEMORI Corps intervention (vs. wait list control group) in 60 community-living person's living with demential (PLWD) and informal caregiver dyads and 36 volunteer companion guides from geographically and demographically diverse regions in Maryland.

Aim 3: Evaluate the feasibility of ascertainment of community-living PLWD, caregiver, and volunteer-level outcomes over time using virtual and telephonic data collection methods.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 115 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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,
• 21 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:

• English-speaking,
• 55 years or older, (3) High School diploma or General Equivalency Diploma (GED) (minimum) (2) ability pass a basic adult literacy screen
• Ability to pass a background check, physical and mental health screening,
• A Montreal Cognitive Assessment (MoCA)-Blind score of 18 or above,
• Ability to commit to 12 months of service (5 hours per week, excluding travel time and continuing education and support), and
• Are reliable during intake and on-boarding process and able to successfully complete training.

Exclusion Criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Intervention; Intervention arm with MEMORI Corps program	Behavioral: MEMORI Corps program; 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.
Other: Control; Augmented waitlist control.	Other: Augmented Waitlist Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver Time Spent Helping Person Living With Dementia	Two individual items ask caregivers to estimate hours per day spent doing caregiving activities, and hours per day spent with the person with dementia in a typical week. Objective measure of caregiver burden. Higher time estimates in performing these tasks indicate greater objective burden.	Baseline - 12 weeks
Change in Depressive Symptoms in Senior Companion Volunteers 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 in senior companion volunteers. 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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 12, 2024
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: community-based; volunteer; home-based; activity; dementia care; caregiver support; companion care; caregiver wellbeing; caregiver respite
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Behavior; Alzheimer Disease; Dementia; Motor Activity
• Other Study ID Numbers: IRB00197899; R01AG058586 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results and learning from this Phase III randomized controlled trial (RCT) will be strategically disseminated to a variety of stakeholders (persons with dementia, family caregivers, partners, advocacy organizations, volunteer organizations, community-based organizations, state and federal policy makers, regulators, health and supportive care services providers, health organizations and health system decision makers) and in a variety of formats (peer reviewed publications, professional and scientific conferences, community lectures, popular press articles, briefs, blog posts). Messaging will be specifically tailored to stakeholder groups to support the effective communication of the science and key findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No