Culturally Responsive Caregiver Support

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04856462

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological Adaptation, Psychological	Behavioral: Education Support Behavioral: Phone Call	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to an intervention group where they will receive structured education and support or to control group where they will participate in a group call.Participants will be randomly assigned to an intervention group where they will receive structured education and support or to control group where they will participate in a group call.

Masking:

Double (Participant, Care Provider)

Masking Description:

Participants and group facilitators in the control group will made aware that they are part of the control gropu

Primary Purpose:

Supportive Care

Official Title:

Culturally Responsive Support Programming for Black Caregivers of Persons With Dementia

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education Support Group Caregivers receiving structured education and support	Behavioral: Education Support Structured education is provided each week to family caregivers over the course of 12 weeks along with facilitated telephone group meetings.
Active Comparator: Control Group Caregivers participating in weekly support calls	Behavioral: Phone Call Participants will participate in an unstructored support group phone call Other Names: Control Group

Arm

Intervention/Treatment

Experimental: Education Support Group

Caregivers receiving structured education and support

Behavioral: Education Support

Structured education is provided each week to family caregivers over the course of 12 weeks along with facilitated telephone group meetings.

Active Comparator: Control Group

Caregivers participating in weekly support calls

Behavioral: Phone Call

Participants will participate in an unstructored support group phone call

Other Names:

Control Group

Outcome Measures

Primary Outcome Measures

Caregiver Self-efficacy [From start of study to 6 months following end of study enrollment up to 9 months]
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%

Secondary Outcome Measures

Positive Aspects of Caregiving [From start of study to 6 months following end of study enrollment up to 9 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Self-identified as Black/ African American
At least 55 years old
Able to speak and understand 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
Is responsible for, monitors, and/ or provides assistance in activities of daily living for the care recipient as a family/friend unpaid responsibility
Score of 14 or higher on the Animal Naming Test.
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheria Robinson-Lane, Assistant Professor, University of Michigan

ClinicalTrials.gov Identifier:

NCT04856462

Other Study ID Numbers:

HUM00185043

First Posted:

Apr 23, 2021

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress, Psychological

Study Results

No Results Posted as of Apr 1, 2022