Alzheimer Disease, Dementia
Conditions
Keywords
dementia care, community-based, companion care, activity, caregiver wellbeing, caregiver respite, caregiver support, home-based, volunteer
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.
Interventions
BEHAVIORALMEMORI 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.
OTHERAugmented 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.
Sponsors
Johns Hopkins University
Alzheimer's Association
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Single blind, pilot, randomized controlled trial where outcome assessors are masked to treatment arm allocation.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 115 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score | Baseline - 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 | Baseline - 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 | Baseline - 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) - 8 | Baseline - 12 weeks | 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. |
| Change in Perceived Loneliness as Measured by UCLA 3 Loneliness Scale | Baseline - 12 weeks | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. |
| Change in Perceived Loneliness for Caregiver as Measured by UCLA 3 Loneliness Scale | Baseline - 12 weeks | Three item measure of perceived loneliness and social isolation. Scores range from 3-9 with higher scores indicating higher levels of loneliness. |
| Program Satisfaction and Perceived Impact Survey | 12-weeks post intervention | 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 |
| Change in Perceived Impact of Leisure Activities as Measured by Leisure Activity Participation Impact Scale | Baseline - 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Time Spent Helping Person Living With Dementia | Baseline - 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 Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8 | Baseline -12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORQuincy Samus, PhD
Johns Hopkins University
Participant flow
Recruitment details
Overall, we received over 650 community-based referrals from over 20 unique community-based referral sources (including health care and non-health care related sources).
Pre-assignment details
Completed enrollment of 175 individual participants. 173 were randomized (61 Persons Living With Dementia (PLWD), 61 Family Caregivers, 51 Volunteer/Companion Guides). 1 dyad was inadvertently not randomized after baseline and excluded from analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical Dementia Caregivers <=18 years | 0 Participants |
| Age, Categorical Dementia Caregivers >=65 years | 16 Participants |
| Age, Categorical Dementia Caregivers Between 18 and 65 years | 23 Participants |
| Age, Categorical Persons living with dementia <=18 years | 0 Participants |
| Age, Categorical Persons living with dementia >=65 years | 53 Participants |
| Age, Categorical Persons living with dementia Between 18 and 65 years | 8 Participants |
| Age, Categorical Volunteer Companion Guides <=18 years | 0 Participants |
| Age, Categorical Volunteer Companion Guides >=65 years | 15 Participants |
| Age, Categorical Volunteer Companion Guides Between 18 and 65 years | 10 Participants |
| Age, Continuous Dementia Caregivers | 64.64 years STANDARD_DEVIATION 9.99 |
| Age, Continuous Persons living with dementia | 76.85 years STANDARD_DEVIATION 8.77 |
| Age, Continuous Volunteer Companion Guides | 66.16 years STANDARD_DEVIATION 7.92 |
| Caregiver Time Spent Helping PLWD in Last Week | 50.84 hours per week STANDARD_DEVIATION 47.07 |
| Caregiver UCLA 3 Loneliness Scale | 5.00 units on a scale STANDARD_DEVIATION 1.72 |
| Leisure Activity Participation Impact Scale | 41.66 units on a scale STANDARD_DEVIATION 6.8 |
| Neuropsychiatric Inventory (NPI) Score | 21.80 units on a scale STANDARD_DEVIATION 19.36 |
| Patient Health Questionnaire (PHQ) - 8 | 4.14 units on a scale STANDARD_DEVIATION 4.69 |
| Quality of Life in Alzheimer's Disease (QOL-AD) | 33.54 units on a scale STANDARD_DEVIATION 6.29 |
| Race (NIH/OMB) Dementia Caregiver American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Dementia Caregiver Asian | 1 Participants |
| Race (NIH/OMB) Dementia Caregiver Black or African American | 23 Participants |
| Race (NIH/OMB) Dementia Caregiver More than one race | 0 Participants |
| Race (NIH/OMB) Dementia Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Dementia Caregiver Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Dementia Caregiver White | 14 Participants |
| Race (NIH/OMB) Person Living with Dementia American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Person Living with Dementia Asian | 0 Participants |
| Race (NIH/OMB) Person Living with Dementia Black or African American | 11 Participants |
| Race (NIH/OMB) Person Living with Dementia More than one race | 0 Participants |
| Race (NIH/OMB) Person Living with Dementia Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Person Living with Dementia Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Person Living with Dementia White | 39 Participants |
| Race (NIH/OMB) Volunteer Companion Guide American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Volunteer Companion Guide Asian | 0 Participants |
| Race (NIH/OMB) Volunteer Companion Guide Black or African American | 3 Participants |
| Race (NIH/OMB) Volunteer Companion Guide More than one race | 1 Participants |
| Race (NIH/OMB) Volunteer Companion Guide Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Volunteer Companion Guide Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Volunteer Companion Guide White | 14 Participants |
| Senior Companion Volunteers Patient Health Questionnaire ( | 1.46 units on a scale STANDARD_DEVIATION 1.88 |
| Sex: Female, Male Dementia Caregiver Female | 23 Participants |
| Sex: Female, Male Dementia Caregiver Male | 5 Participants |
| Sex: Female, Male Person Living with Dementia Female | 26 Participants |
| Sex: Female, Male Person Living with Dementia Male | 35 Participants |
| Sex: Female, Male Volunteer Companion Guide Female | 22 Participants |
| Sex: Female, Male Volunteer Companion Guide Male | 4 Participants |
| UCLA 3 Loneliness Scale | 4.05 units on a scale STANDARD_DEVIATION 1.6 |
| Zarit Burden Inventory-Short Form | 16.51 units on a scale STANDARD_DEVIATION 7.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 1 / 24 | 0 / 28 | 0 / 27 | 0 / 28 | 0 / 27 |
| other Total, other adverse events | 0 / 33 | 0 / 24 | 0 / 28 | 0 / 27 | 0 / 22 | 0 / 5 |
| serious Total, serious adverse events | 0 / 33 | 0 / 24 | 0 / 28 | 0 / 27 | 0 / 22 | 0 / 5 |
Outcome results
None listed