Culturally Responsive Caregiver Support

Stress, Psychological Clinical Trial

Official title:

Culturally Responsive Support Programming for Black Caregivers of Persons With Dementia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04856462
• Other study ID #: HUM00185043
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Sheria G Robinson-Lane, PhD
• Phone: 734-764-9280
• Email: grices[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed intervention is a telephonically-based support program that will follow a peer supportive model to engage small groups of caregivers over 12 weeks. During each week of the intervention, participants (n = 36, 4/ group) will engage in a small facilitator lead, support group. Each week, caregivers will be provided with a different culturally relevant caregiving or personal health strategy to practice. During the weekly 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 found barriers to it. The format will be structured enough to ensure that content is covered and everyone is able to be equally engaged while flexible enough that caregivers can receive support in the areas they need. A battery of assessment measures will be taken prior to the start of the intervention, halfway through at 6 weeks, at 12 weeks, 30 days following the intervention, and then 6 months following the intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Self-identified as Black/ African American

2. At least 55 years old

3. Able to speak and understand English

4. 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

5. Is responsible for, monitors, and/ or provides assistance in activities of daily living for the care recipient as a family/friend unpaid responsibility

6. Score of 14 or higher on the Animal Naming Test.

7. Able to adequately hear by phone to engage with the group Exclusion Criteria: Caregivers will be excluded from the study if they do not meet the inclusion criteria, decline to participate for any reason, or do not give consent for participation -

Related Conditions & MeSH terms

• Adaptation, Psychological
• Stress, Psychological

Intervention

Behavioral:
• Education Support
Structured education is provided every other week (biweekly) to family caregivers over the course of 12 weeks, along with facilitated video-teleconferencing group meetings.
• Phone Call
Participants will participate in an unstructored support group phone call

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Scoring is collected across three separate domains including ability to obtain respite, control upsetting thoughts, and responding to disruptive behaviors. Scoring measures self-reported from 0-100%	From start of study to 6 months following end of study enrollment up to 9 months
Secondary	Positive Aspects of Caregiving	Positive aspects of caregiving will be measured by the Positive Aspects of Caregiving Scale which provides a cumulative score that maxes at 45 point indicating a high agreement with identifying positive aspects of caregiving despite challenges	From start of study to 6 months following end of study enrollment up to 9 months