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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress, Psychological

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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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

    First Posted
    April 19, 2021
    Last Updated
    October 2, 2023
    Sponsor
    University of Michigan
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    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).

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    Culturally Responsive Caregiver Support

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