MEMORI Corps: Activity-based Companion Care for Dementia (MEMORI Corps)
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|ClinicalTrials.gov Identifier: NCT03896711|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : October 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Dementia||Behavioral: MEMORI Corps program Other: Augmented Waitlist Control||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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|
|Official Title:||MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers|
|Actual Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||September 29, 2024|
|Estimated Study Completion Date :||September 29, 2024|
Experimental: Active Intervention
Intervention arm with MEMORI Corps program
Behavioral: MEMORI Corps program
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.
Augmented waitlist control.
Other: Augmented Waitlist Control
Persons with dementia/caregivers will continue any services and supports being used, will receive a free copy of "A Caregiver's Guide to Dementia: Using Activities and Other Strategies to Prevent, Reduce and Manage Behavioral Symptom"103), written educational materials on management of CG stress/well-being, and bi-weekly check-in calls to answer any questions about the materials. Volunteers randomized to waitlist control will continue with usual activities (volunteer or other), and will receive additional written educational materials on cognitive health (NIA) and exercise and Physical Activity (Go4Life), referrals to the Baltimore City Commission on Aging and Retirement Education for volunteering opportunities, and bi-monthly 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.
- Change in neuropsychiatric symptoms as assessed by Neuropsychiatric Inventory (NPI) score [ Time Frame: Baseline to 12 weeks ]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.
- Change in quality of life as assessed by the Quality of life in Alzheimer's Disease (QOL-AD) tool [ Time Frame: Baseline to 12 weeks ]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.
- Change in subjective caregiver burden as assessed by the Zarit Burden Inventory-Short Form [ Time Frame: Baseline to 12 weeks ]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.
- Change in depressive symptoms in caregivers as assessed by The Patient Health Questionnaire (PHQ) - 9 [ Time Frame: Baseline to 12 weeks ]The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 9 will assess depressive symptoms severity. The PHQ-9 is a self-rated 9 item measure of caregiver depressive symptoms. Scores can range from 0-27, with higher scores indicating greater depressive symptoms.
- Change in speed of processing as assessed by the Pattern Comparison test [ Time Frame: Baseline to 12 weeks ]The total score for the Pattern Comparison test will be used to assess speed of processing changes. The Pattern Comparison test is a neuropsychological test to measure volunteer cognitive speed processing. Higher scores indicate greater speeds of processing.
- Change in Gait speed [ Time Frame: Baseline to 12 weeks ]The time (minutes) it takes subjects to rise from a chair, walk 4 meters, turnaround and sit back down will be used to assess gait speed. This walking speed test to measure volunteer gait disability. Lower time scores indicates better gait functioning.
- Change in executive functioning as assessed by Trail Making Test B [ Time Frame: Baseline to 12 weeks ]The score for the Trail Making Test B will be used to measure volunteer executive functioning. Lower time score indicates better executive functioning.
- Change in activity engagement as assessed by the Community Healthy Activities Model Program for Seniors activity questionnaire [ Time Frame: Baseline to 12 weeks ]The total score from the Community Healthy Activities Model Program for Seniors activity questionnaire will be used to quantify engagement in various forms of activities over the course of a week. Scores can range from 0-168, with higher scores indicating greater activity engagement.
- Change in outpatient health services use as assessed by the Resource Utilization in Dementia/Services Utilization and Resources Survey [ Time Frame: Baseline to 12 weeks ]This is a proxy rated measure (Resource Utilization in Dementia/Services Utilization and Resources Survey; SURFS) of family caregiver outpatient medical services. Total scores are for each category and represent counts of service type encounters (range 0-90) for outpatient medical services, with higher counts indicating more service type utilization.
- Change in home and community-based long term services and supports use health services use as assessed by the Resource Utilization in Dementia/Services Utilization and Resources Survey [ Time Frame: Baseline to 12 weeks ]Community based long term services and supports is summarized by count of service type category, ranging from 0-12, with higher counts indicating more service category utilization.
- Change in objective caregiver burden as assessed by time estimates in performing tasks [ Time Frame: Baseline to 12 weeks ]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.
- Change in stress as assessed by the Elders Life Stress Inventory [ Time Frame: Baseline to 12 weeks ]The investigators will use a total score of the Elders Life Stress Inventory to measure stress ratings by volunteers. The total score ranges from 0-31 and indicates the total sum of 31 different types of stressful life events over the observation period related to several domains of the persons life. Higher counts of stressful events represent greater stress.
- Time to transition from home [ Time Frame: Baseline to 12 weeks ]The investigators will record the time (days) from randomization to transition from home using survival analyses. These exploratory analyses will estimate risk of all-cause transition out of home for person with dementia
- Change in depressive symptoms in senior companion volunteers as assessed by The Patient Health Questionnaire (PHQ) - 9 [ Time Frame: Baseline to 12 weeks ]The total score (sum of items) for the The Patient Health Questionnaire (PHQ) - 9 will assess depressive symptoms severity in senior companion volunteers. The PHQ-9 is a self-rated 9 item measure of caregiver depressive symptoms. Scores can range from 0-27, with higher scores indicating greater depressive symptoms.
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|Ages Eligible for Study:||18 Years to 115 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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 the Clinical Dementia Rating Scale of >0.5
- Are able to participate in >2 basic Activities of Daily Living
- Have not received formal (e.g. in-home companion care, or adult day center) respite care services in the past 4 weeks
- Living at home in Baltimore City or Baltimore County.
CGs are eligible if:
- English speaking
- 18 years of age or older (male or female)
- Are deemed to be a reliable informal caregiver (not paid for their care-giving)
- Are co-residing with the PWD
- Are relied on by the PWD for assistance in activities of daily living (instrumental or basic).
Volunteers are eligible if:
- 55 years or older
- Ability to read
- Ability to pass a criminal background check, drug and physical and mental health screening
- Have reliable transportation and able to travel within 20 miles of home
- A Mini-Mental State Examination score of 24 or above
- Ability to complete the Trail Making Test within specified time limits
- Ability to commit to 12 months of service (10 hours per week excluding travel time)
- Are reliable during intake and on-boarding process.
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, non-communicative, or hospice)
- Are incontinent of urine or bowels
- Are currently enrolled in a dementia related clinical trial
- Deemed to have severe behavioral symptoms 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
- Are currently involved in a behavioral/educational clinical trial.
Volunteers are excluded:
- Are planning on moving from the area in the next 12 months
- Unable to provide informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896711
|Contact: Quincy Samus, PhDfirstname.lastname@example.org|
|Contact: Melissa Reuland, MSemail@example.com|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Morgan Spliedt, MS 410-550-6744 firstname.lastname@example.org|
|Principal Investigator:||Quincy Samus, PhD||Johns Hopkins University|
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
R01AG058586 ( U.S. NIH Grant/Contract )
|First Posted:||April 1, 2019 Key Record Dates|
|Last Update Posted:||October 3, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases