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

MEMORI Corps: Activity-based Companion Care for Dementia

Source: ClinicalTrials.gov NCT03896711 ↗
Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Change in Neuropsychiatric Symptoms as Assessed by Neuropsychiatric Inventory (NPI) Score — 3.35; 0.47 score on a scale

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.

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

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. Informational only — not medical advice.

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