- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992467
WECARE: A Behavioral Intervention for Dementia Caregivers (WECARE)
April 22, 2024 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
Recruiting
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 (Estimated)
45
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 Contact
- Name: Alicia Hong, PhD
- Phone Number: 7039931929
- Email: yhong22@gmu.edu
Study Contact Backup
- Name: Sarah Clark
- Phone Number: 7039936801
- Email: sclark68@gmu.edu
Study Locations
-
-
Virginia
-
Fairfax, Virginia, United States, 22030
- Recruiting
- George Mason University
-
Contact:
- Alicia Hong
- Phone Number: 730-993-1929
- Email: yhong22@gmu.edu
-
-
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 (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
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.
|
Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after 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 (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
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.
|
Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
Efficacy of behavioral intervention in change from baseline in life satisfaction
Time Frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
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.
|
Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of behavioral intervention in change from baseline in caregiving mastery
Time Frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
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.
|
Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
Efficacy of behavioral intervention in change in care-recipient's problem behaviors
Time Frame: Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
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.
|
Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 25, 2023
Primary Completion (Estimated)
May 31, 2024
Study Completion (Estimated)
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)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
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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