Culturally Responsive Caregiver Support
Primary Purpose
Stress, Psychological, Adaptation, Psychological
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education Support
Phone Call
Sponsored by
About this trial
This is an interventional supportive care trial for Stress, Psychological
Eligibility Criteria
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
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Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education Support Group
Control Group
Arm Description
Caregivers receiving structured education and support
Caregivers participating in weekly support calls
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04856462
Brief Title
Culturally Responsive Caregiver Support
Official Title
Culturally Responsive Support Programming for Black Caregivers of Persons With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Adaptation, Psychological
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
Participants and group facilitators in the control group will made aware that they are part of the control gropu
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Education Support Group
Arm Type
Experimental
Arm Description
Caregivers receiving structured education and support
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Caregivers participating in weekly support calls
Intervention Type
Behavioral
Intervention Name(s)
Education Support
Intervention Description
Structured education is provided every other week (biweekly) to family caregivers over the course of 12 weeks, along with facilitated video-teleconferencing group meetings.
Intervention Type
Behavioral
Intervention Name(s)
Phone Call
Other Intervention Name(s)
Control Group
Intervention Description
Participants will participate in an unstructored support group phone call
Primary Outcome Measure Information:
Title
Caregiver Self-efficacy
Description
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%
Time Frame
From start of study to 6 months following end of study enrollment up to 9 months
Secondary Outcome Measure Information:
Title
Positive Aspects of Caregiving
Description
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
Time Frame
From start of study to 6 months following end of study enrollment up to 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheria G Robinson-Lane, PhD
Phone
734-764-9280
Email
grices@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Giordani, PhD
Phone
734-764-0231
Email
giordani@umich.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
It is anticipated that the following data will be generated and made available 1) published tables, figures, graphs, and tables of data used for making graphs; 2) published journal papers, conference papers, annual reports and the final report; and 3) educational materials resulting from intervention development. All data will conform with relevant data and terminology standards.
IPD Sharing Time Frame
No less than 5 years following the date of the project completion or the date of study publication.
IPD Sharing Access Criteria
To facilitate data sharing, project data will be made publicly available via a university-controlled repository Deep Blue (http://deepblue.lib.umich.edu).
Learn more about this trial
Culturally Responsive Caregiver Support
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