- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992467
WECARE: A Behavioral Intervention for Dementia Caregivers (WECARE)
June 7, 2026 updated by: Y. Alicia Hong, George Mason University
WECARE: A mHealth Intervention to Enhance Caregiving Mastery Among Chinese American Dementia Caregivers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Fairfax, Virginia, United States, 22030
- George Mason University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WECARE
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
The baseline and follow-up differences in depressive symptoms will be assessed using the Center for Epidemiologic Studies Depression Scale (CES-D).
The CES-D is a 20-item survey instrument designed to measure the frequency and severity of depressive symptoms.
The total score is calculated by summing the responses to all 20 items.
The total scale ranges from 0 to 60, with higher scores indicating more severe depressive symptoms (a worse outcome).
The primary analysis will calculate the difference in this total score between baseline and follow-up.
adults and dementia caregivers.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Burden
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
The baseline and follow-up differences in caregiving burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12).
The ZBI-12 is designed to measure the subjective physical, psychological, and social burden experienced by caregivers.
Each item is rated on a 5-point scale from "never" (0) to "nearly always" (4), The total score is calculated by summing the responses to all 12 items.
The total scale ranges from 0 to 48, with higher scores indicating greater caregiving burden (a worse outcome).
The primary analysis will calculate the difference in this total score between baseline and follow-up.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
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Efficacy of Behavioral Intervention in Change From Baseline in Life Satisfaction
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
The baseline and follow-up differences in life satisfaction will be assessed using the Satisfaction with Life Scale (SWLS).
The SWLS is a 5-item survey instrument designed to measure a person's global cognitive judgments of satisfaction with their life.
The total score is calculated by summing the responses to all 5 items.
The total scale ranges from 0 to 30, with higher scores indicating greater life satisfaction (a better outcome).
The primary analysis will calculate the difference in this total score between baseline and follow-up.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Mastery
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
The baseline and follow-up differences in caregiving mastery will be assessed using the Caregiving Mastery Scale.
This 7-item survey instrument is designed to measure a caregiver's self-perception of their ability to effectively manage caregiving tasks and challenges.
The total score is calculated by summing the responses to all 7 items.
The total scale ranges from 0 to 28, with higher scores indicating greater caregiving mastery (a better outcome).
The primary analysis will calculate the difference in this total score between baseline and follow-up.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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Efficacy of Behavioral Intervention in Change in Care-recipient's Problem Behaviors
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
The baseline and follow-up differences in care-recipient problem behaviors will be assessed using the Revised Memory and Problem Behavior Checklist (RMBPC).
The RMBPC is a 24-item survey instrument designed to measure observable behavioral problems in care recipients across three subdomains: memory-related issues, depressive behaviors, and disruptive behaviors.
The total score is calculated by summing the Yes (1) or No (0) responses to all 24 items.
The total scale ranges from 0 to 24, with higher scores indicating a higher frequency of problem behaviors (a worse outcome).
The primary analysis will calculate the difference in this total score between baseline and follow-up.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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Efficacy of Behavioral Intervention in Change From Baseline in Positive Aspect of Caregiving
Time Frame: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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The baseline and follow-up differences in caregivers' positive aspects of caregiving will be measured by Positive Aspects of Caregiving Scale, a 9-item scale 5-point Likert scale from 0 to 4, with total scores ranging from 0 to 36, with higher score indicating more positive perception of caregiving.
The baseline and follow-up differences in the scores will be calculated.
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Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alicia Hong, George Mason University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
August 31, 2024
Study Completion (Actual)
August 31, 2024
Study Registration Dates
First Submitted
July 6, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 9, 2026
Last Update Submitted That Met QC Criteria
June 7, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- George Mason University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Given the small sample size, we will not make individual participant data available to the public.
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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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