The Alzheimer's Companion Engagement (ACE) Project.

NCT04856462 | Completed

• 2 other identifiers: HUM002309401K01AG065420-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress, Psychological; Adaptation, Psychological

Outcome Measures

Primary Outcomes (1)

• Caregiver Self-efficacy

  Caregiver self-efficacy will be measured by the Revised Scale for Caregiving Self-Efficacy, which evaluates the caregivers' ability to obtain respite care, respond to disruptive behaviors, and control one's own upsetting thoughts about caregiving.

  6 weeks

Secondary Outcomes (1)

• Positive Aspects of Caregiving

  6 weeks

Study Arms (1)

Caregiver Support

EXPERIMENTAL

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

Behavioral: Education Support

Interventions

Education Support 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.

Caregiver Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be assigned to intervention groups where they will receive structured education and support.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 23, 2021
• Study Start: March 6, 2025
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: No less than 5 years following the date of the project completion or the date of study publication.
• Access Criteria: To facilitate data sharing, project data will be made publicly available via a university-managed repository Deep Blue.

Locations

US (1)