The Alzheimer's Companion Engagement (ACE) Project.

NCT ID: NCT04856462

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2025-10-22

Brief Summary

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Black family caregivers of older adults with Alzheimer's disease and/or related dementias (ADRD), have an increased mortality risk related to pre-existing health conditions and stress. Targeted, culturally responsive, health interventions that help Black ADRD caregivers to effectively manage their own health and use community preferenced ways of coping, can improve caregivers' overall health, perceived ability to provide care for a person with ADRD (self-efficacy), and increases the likelihood that they will experience benefits from caregiving. This clinical trial pilot will test the feasibility of a community based intervention designed to improve health outcomes for Black family caregivers of persons with ADRD.

Detailed Description

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The proposed intervention is a peer-supportive and facilitator-led video teleconference program that will engage small groups of caregivers weekly over 6 weeks. Each week participants (n = 36, 2-5/group) will receive a different culturally relevant caregiving or personal health strategy to practice. During the support calls, a facilitator will provide an overview of the content covered and each participant will have the opportunity to discuss their past week and how they engaged the weekly strategy, or challenges that came up for them during the week. The format will be structured to ensure that core content is reviewed, and everyone can be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken at weeks 1 and 8.

Conditions

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Stress, Psychological Adaptation, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be assigned to intervention groups where they will receive structured education and support.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Caregiver Support

All participants in all groups will receive 6 weeks of caregiving support including a weekly video/teleconference call, and handouts covering relevant educational topics)

Group Type EXPERIMENTAL

Education Support

Intervention Type BEHAVIORAL

Caregivers engage in a weekly video/teleconference support group with a skilled facilitator to discuss various strategies for managing caregiving stress, challenging behaviors, and personal self-care.

Interventions

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Education Support

Caregivers engage in a weekly video/teleconference support group with a skilled facilitator to discuss various strategies for managing caregiving stress, challenging behaviors, and personal self-care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Self-identified as Black/ African American At least 18 years old Able to speak, understand, and hear spoken English Related to, or has a close personal relationship to a person over the age of 55 that has an ADRD diagnosis or evidence of cognitive impairment Regular access to a smartphone, tablet or computer with internet access that will allow video conferencing engagement.

Provides monitoring, and assistance in activities of daily living and or other care tasks for the care recipient.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Sheria Robinson-Lane

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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1K01AG065420-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00230940

Identifier Type: -

Identifier Source: org_study_id

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