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WECARE: A Behavioral Intervention for Dementia Caregivers (WECARE)

Primary Purpose

Caregiver Burden, Caregiver Stress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wellness Enhancement for Caregivers (WECARE)
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burden

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 21 years or older, self-identified as Chinese or Chinese American, speak and read Chinese (Mandarin or Cantonese), own a smartphone and use WeChat, living in Washington DC metropolitan, and currently care for a family member with ADRD and provide care for at least 10 hours a week. Exclusion Criteria: do not read or speak Chinese, care-recipient is in hospice care or have a life expectancy less than 6 months, signs of severe intellectual deficits or psychotic disorders, or unable to provide informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    WECARE

    Arm Description

    Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online.

    Outcomes

    Primary Outcome Measures

    Efficacy of behavioral intervention in change from baseline in depressive symptoms
    The baseline and follow-up differences in depressive symptoms will be assessed. Depressive symptoms will be measured by the CES-D, a 20-item survey instrument. The total score will be calculated to quantify depressive symptoms. The baseline and follow-up differences in the scores will be calculated.

    Secondary Outcome Measures

    Efficacy of behavioral intervention in change from baseline in caregiving burden
    The baseline and follow-up differences in caregiving burden will be assessed. Caregiving burden will be measured by the Zarit Burden Interview, a 12-item survey instrument. The total score will be calculated to quantify caregiving burden. The baseline and follow-up differences in the scores will be calculated.
    Efficacy of behavioral intervention in change from baseline in life satisfaction
    The baseline and follow-up differences in life satisfaction will be assessed. Life satisfaction will be measured by the Life Satisfaction Scale, a 5-item survey instrument. The total score will be calculated to quantify life satisfaction. The baseline and follow-up differences in the scores will be calculated.

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    August 22, 2023
    Sponsor
    George Mason University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05992467
    Brief Title
    WECARE: A Behavioral Intervention for Dementia Caregivers
    Acronym
    WECARE
    Official Title
    WECARE: A mHealth Intervention to Enhance Caregiving Mastery Among Chinese American Dementia Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    George Mason University

    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
    This study aims to pilot test a culturally tailored behavioral intervention called "WECARE" to enhance caregiving mastery and improve psychosocial wellbeing of Chinese American family caregivers of persons with Alzheimer's Disease and related dementia.
    Detailed Description
    The investigators propose to test a culturally tailored mHealth behavioral intervention to enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family caregivers of persons living with Alzheimer's Disease and related dementia. This intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a social media app highly popular among Chinese Americans. About 45 participants will be recruited for the pilot test. Participants will complete a baseline survey, receive 7-week WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the baseline, and then a qualitative interview on Zoom.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver Burden, Caregiver Stress Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    WECARE
    Arm Type
    Experimental
    Arm Description
    Participants will first complete a baseline survey online, then subscribe to the WECARE official account on their own WeChat accounts and begin receiving the 7-week interactive and personalized program. The program content includes short video clips, pictorial messages, and audio recordings. Each week, the WECARE program is focused on a theme aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Four weeks after the intervention or 11 weeks after the baseline, participants will complete a follow-up survey online.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Wellness Enhancement for Caregivers (WECARE)
    Intervention Description
    WECARE behavioral intervention is guided by behavioral theories aimed to increase participants' caregiving mastery, enhance self-care, and improve psychosocial wellbeing. Participants will receive multimedia content on their WeChat account on cellphone or tablet, including short video clips, pictorial messages, short articles, and audio recordings 6 days a week, for 7 weeks.
    Primary Outcome Measure Information:
    Title
    Efficacy of behavioral intervention in change from baseline in depressive symptoms
    Description
    The baseline and follow-up differences in depressive symptoms will be assessed. Depressive symptoms will be measured by the CES-D, a 20-item survey instrument. The total score will be calculated to quantify depressive symptoms. The baseline and follow-up differences in the scores will be calculated.
    Time Frame
    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
    Secondary Outcome Measure Information:
    Title
    Efficacy of behavioral intervention in change from baseline in caregiving burden
    Description
    The baseline and follow-up differences in caregiving burden will be assessed. Caregiving burden will be measured by the Zarit Burden Interview, a 12-item survey instrument. The total score will be calculated to quantify caregiving burden. The baseline and follow-up differences in the scores will be calculated.
    Time Frame
    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
    Title
    Efficacy of behavioral intervention in change from baseline in life satisfaction
    Description
    The baseline and follow-up differences in life satisfaction will be assessed. Life satisfaction will be measured by the Life Satisfaction Scale, a 5-item survey instrument. The total score will be calculated to quantify life satisfaction. The baseline and follow-up differences in the scores will be calculated.
    Time Frame
    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
    Other Pre-specified Outcome Measures:
    Title
    Efficacy of behavioral intervention in change from baseline in caregiving mastery
    Description
    The baseline and follow-up differences in caregiving mastery will be assessed. Caregiving mastery will be measured by the Caregiving Mastery Scale, a 7-item survey instrument. The total score will be calculated to quantify caregiving mastery. The baseline and follow-up differences in the scores will be calculated.
    Time Frame
    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
    Title
    Efficacy of behavioral intervention in change in care-recipient's problem behaviors
    Description
    The baseline and follow-up differences in care-recipient's problem behaviors will be assessed. Care-recipient's problem behaviors will be measured by a list of 20-item problem behaviors. The total score will be calculated to quantify the number of problem behaviors. The baseline and follow-up differences in the scores will be calculated.
    Time Frame
    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 21 years or older, self-identified as Chinese or Chinese American, speak and read Chinese (Mandarin or Cantonese), own a smartphone and use WeChat, living in Washington DC metropolitan, and currently care for a family member with ADRD and provide care for at least 10 hours a week. Exclusion Criteria: do not read or speak Chinese, care-recipient is in hospice care or have a life expectancy less than 6 months, signs of severe intellectual deficits or psychotic disorders, or unable to provide informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alicia Hong, PhD
    Phone
    7039931929
    Email
    yhong22@gmu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Clark
    Phone
    7039936801
    Email
    sclark68@gmu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    After the investigators completes primary data collection and the first report from this trial is accepted for publication.
    IPD Sharing Access Criteria
    Researchers will submit a request including the purpose of accessing the data and a data user agreement

    Learn more about this trial

    WECARE: A Behavioral Intervention for Dementia Caregivers

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