Clinical trial NCT03896711: MEMORI Corps: Activity-based Companion Care for Dementia
Official title: MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: dementia care
community-based
companion care
activity
caregiver wellbeing
caregiver respite
caregiver support
home-based
volunteer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
name: National Institute on Aging (NIA)
First posted: 2019-04-01
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 115
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in neuropsychiatric symptoms as assessed by Neuropsychiatric Inventory (NPI) score
timeFrame: Baseline to 12 weeks
measure: Change in quality of life as assessed by the Quality of life in Alzheimer's Disease (QOL-AD) tool
timeFrame: Baseline to 12 weeks
measure: Change in subjective caregiver burden as assessed by the Zarit Burden Inventory-Short Form
timeFrame: Baseline to 12 weeks
measure: Change in depressive symptoms in caregivers as assessed by The Patient Health Questionnaire (PHQ) - 8
timeFrame: Baseline to 12 weeks
measure: Change in activity engagement as assessed by the Community Healthy Activities Model Program for Seniors activity questionnaire
timeFrame: Baseline to 12 weeks
measure: Change in perceived loneliness as measured by UCLA 3 loneliness scale
timeFrame: Baseline to 12 weeks
measure: Change in perceived loneliness for caregiver as measured by UCLA 3 loneliness scale
timeFrame: Baseline to 12 weeks
measure: Feasibility and acceptability as measures by the MEMORI Corps satisfaction survey for persons living with dementia and their informal caregivers
timeFrame: 12-weeks post intervention
measure: Feasibility and acceptability as measures by the MEMORI Corps satisfaction survey for companion guides
timeFrame: 12-weeks post intervention
measure: change in perceived impact of leisure activities as measured by Leisure Activity Participation Impact Scale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in objective caregiver burden as assessed by time estimates in performing tasks
timeFrame: Baseline to 12 weeks
measure: Change in depressive symptoms in senior companion volunteers as assessed by The Patient Health Questionnaire (PHQ) - 8
timeFrame: Baseline to 12 weeks
measure: Change in self-reported balance as assessed by the Centers for Disease Control Stopping Elderly Accidents, Deaths & Injuries (CDC STEADI-3)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Quincy Samus, PhD
role: PRINCIPAL_INVESTIGATOR
References: