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Alzheimer DiseaseMEMORI CorpsNCT03896711

MEMORI Corps: Activity-based Companion Care for Dementia

A study testing MEMORI Corps program in people with Alzheimer Disease and Dementia, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 115 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease, Dementia
What is being tested?
MEMORI Corps program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 31 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 115 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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).
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
MEMORI Corps program, Augmented Waitlist Control
Keywords
dementia care, community-based, companion care, activity, caregiver wellbeing, caregiver respite, caregiver support, home-based, volunteer
Medical subject headings
Alzheimer Disease, Dementia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEMORI Corps programBehavioural

    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.

  • Augmented Waitlist ControlOther

    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.

Study groups in NCT03896711
Study groupRoleWhat they receive
Active InterventionExperimentalIntervention arm with MEMORI Corps program
Receives: Behavioral: MEMORI Corps program
ControlOtherAugmented waitlist control.
Receives: Other: Augmented Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline - 12 weeks

  2. 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.

    Measured: Baseline - 12 weeks

  3. 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.

    Measured: Baseline - 12 weeks

  4. 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.

    Measured: Baseline - 12 weeks

  5. 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.

    Measured: Baseline - 12 weeks

  6. 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.

    Measured: Baseline - 12 weeks

  7. 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

    Measured: 12-weeks post intervention

  8. 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

    Measured: Baseline - 12 weeks

Secondary outcomes (2)
  1. 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.

    Measured: Baseline - 12 weeks

  2. 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.

    Measured: Baseline -12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start1 Mar 2022
  3. Primary completion12 Aug 2024
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896711
Sponsor's protocol ID
IRB00197899
Other IDs
R01AG058586
Acronym
MEMORI Corps
Status last verified
Jan 2026
First submitted
28 Mar 2019
Last updated
28 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MEMORI Corps program in people with Alzheimer Disease and Dementia, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score (time frame: Baseline - 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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