- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07539350
Wellness Enhancement for Caregivers (WECARE)
WECARE: A Personalized Intervention for Underserved Chinese American Dementia Caregivers
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- currently residing in the United States,
- self-identify as Chinese or Chinese American and are able to read in Chinese,
- are 21 years of age or older,
- own a cellphone and use WeChat, and
- provide at least 8 hours of care per week to a family member or loved one with ADRD.
Exclusion Criteria:
(1) evidence of severe cognitive impairment or mental disorders, or (2) the care recipient was receiving hospice care or had a life expectancy of fewer than six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
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.
|
The 7-week WECARE intervention was designed to improve caregiving skills, alleviate caregiver distress, and enhance the psychosocial well-being of dementia caregivers.
|
|
No Intervention: Control group
No intervention for the control group during the intervention period.
|
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. |
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
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.
|
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
|
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.
|
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
|
|
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.
|
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)
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOD00001003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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