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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03896711




Registration number
NCT03896711
Ethics application status
Date submitted
28/03/2019
Date registered
1/04/2019

Titles & IDs
Public title
MEMORI Corps: Activity-based Companion Care for Dementia
Scientific title
MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers
Secondary ID [1] 0 0
R01AG058586
Secondary ID [2] 0 0
IRB00197899
Universal Trial Number (UTN)
Trial acronym
MEMORI Corps
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - MEMORI Corps program
Other interventions - Augmented Waitlist Control

Experimental: Active Intervention - Intervention arm with MEMORI Corps program

Other: Control - Augmented waitlist control.


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.

Other interventions: 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.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in neuropsychiatric symptoms as assessed by Neuropsychiatric Inventory (NPI) score
Timepoint [1] 0 0
Baseline to 12 weeks
Primary outcome [2] 0 0
Change in quality of life as assessed by the Quality of life in Alzheimer's Disease (QOL-AD) tool
Timepoint [2] 0 0
Baseline to 12 weeks
Primary outcome [3] 0 0
Change in subjective caregiver burden as assessed by the Zarit Burden Inventory-Short Form
Timepoint [3] 0 0
Baseline to 12 weeks
Primary outcome [4] 0 0
Change in depressive symptoms in caregivers as assessed by The Patient Health Questionnaire (PHQ) - 8
Timepoint [4] 0 0
Baseline to 12 weeks
Primary outcome [5] 0 0
Change in activity engagement as assessed by the Community Healthy Activities Model Program for Seniors activity questionnaire
Timepoint [5] 0 0
Baseline to 12 weeks
Primary outcome [6] 0 0
Change in perceived loneliness as measured by UCLA 3 loneliness scale
Timepoint [6] 0 0
Baseline to 12 weeks
Primary outcome [7] 0 0
Change in perceived loneliness for caregiver as measured by UCLA 3 loneliness scale
Timepoint [7] 0 0
Baseline to 12 weeks
Primary outcome [8] 0 0
Feasibility and acceptability as measures by the MEMORI Corps satisfaction survey for persons living with dementia and their informal caregivers
Timepoint [8] 0 0
12-weeks post intervention
Primary outcome [9] 0 0
Feasibility and acceptability as measures by the MEMORI Corps satisfaction survey for companion guides
Timepoint [9] 0 0
12-weeks post intervention
Primary outcome [10] 0 0
change in perceived impact of leisure activities as measured by Leisure Activity Participation Impact Scale
Timepoint [10] 0 0
Baseline to 12 weeks
Secondary outcome [1] 0 0
Change in objective caregiver burden as assessed by time estimates in performing tasks
Timepoint [1] 0 0
Baseline to 12 weeks
Secondary outcome [2] 0 0
Change in depressive symptoms in senior companion volunteers as assessed by The Patient Health Questionnaire (PHQ) - 8
Timepoint [2] 0 0
Baseline to 12 weeks
Secondary outcome [3] 0 0
Change in self-reported balance as assessed by the Centers for Disease Control Stopping Elderly Accidents, Deaths & Injuries (CDC STEADI-3)
Timepoint [3] 0 0
Baseline to 12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
115 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2024
Sample size
Target
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Other
Name
Johns Hopkins University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alzheimer's Association
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Institute on Aging (NIA)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Quincy Samus, PhD
Address 0 0
Johns Hopkins University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03896711