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N/A N=173 Randomized Single-blind Supportive Care

MEMORI Corps: Activity-based Companion Care for Dementia

Alzheimer Disease · Dementia

Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score — 3.35; 0.47 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
MEMORI Corps program (Behavioral); Augmented Waitlist Control (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score
3.35; 0.47
PRIMARY
Change in Quality of Life as Assessed by the Quality of Life in Alzheimer's Disease (QOL-AD) Tool
0.21; -0.44
PRIMARY
Change in Subjective Caregiver Burden as Assessed by the Zarit Burden Inventory-Short Form
0.04; -0.69
PRIMARY
Change in Depressive Symptoms in Caregivers as Assessed by The Patient Health Questionnaire (PHQ) - 8
0.38; 0.59
PRIMARY
Change in Perceived Loneliness as Measured by UCLA 3 Loneliness Scale
0.20; -0.42
PRIMARY
Change in Perceived Loneliness for Caregiver as Measured by UCLA 3 Loneliness Scale
-0.39; 0.10
PRIMARY
Program Satisfaction and Perceived Impact Survey
124.15
PRIMARY
Change in Perceived Impact of Leisure Activities as Measured by Leisure Activity Participation Impact Scale
-1.71; -1.63
SECONDARY
Change in Caregiver Time Spent Helping Person Living With Dementia
-14.04; -0.96
SECONDARY
Change in Depressive Symptoms in Senior Companion Volunteers as Assessed by The Patient Health Questionnaire (PHQ) - 8
1.02; 0.80

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.

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03896711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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