MEMORI Corps: A Novel Activity-based Companion Care Program to Benefit Community-living Persons With Dementia, Their Families, and Senior Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind, pilot, randomized controlled trial where outcome assessors are masked to treatment arm allocation.
入排标准
- 年龄范围
- 18 Years 至 115 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Active Intervention
Intervention arm with MEMORI Corps program
干预措施: MEMORI Corps program (Behavioral)
Control
Augmented waitlist control.
干预措施: Augmented Waitlist Control (Other)
结局指标
主要结局
Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Change in Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8(Baseline -12 weeks)
- Change in Caregiver Time Spent Helping Person Living With Dementia(Baseline - 12 weeks)