Caregiver BurdenWECARENCT05992467
WECARE: A Behavioral Intervention for Dementia Caregivers
A study testing Wellness Enhancement for Caregivers (WECARE) in people with Caregiver Burden and Caregiver Stress Syndrome, run by George Mason University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Caregiver Stress Syndrome
- What is being tested?
- Wellness Enhancement for Caregivers (WECARE)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Caregiver Burden, Caregiver Stress Syndrome
- Being tested
- Wellness Enhancement for Caregivers (WECARE)
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness Enhancement for Caregivers (WECARE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WECARE | Experimental | 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. Receives: Behavioral: Wellness Enhancement for Caregivers (WECARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Behavioral Intervention in Change From Baseline in Depressive Symptoms
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.
Measured: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
Secondary outcomes (2)
Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Burden
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.
Measured: 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 Life Satisfaction
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.
Measured: Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Y. Alicia Hong, George Mason University
- Investigators
- Alicia Hong, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992467
- Sponsor's protocol ID
- George Mason University
- Acronym
- WECARE
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2023
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Given the small sample size, we will not make individual participant data available to the public.
Publications
Shen K, Hong YA, Zhang YJ, Han HR, Lin J, Hepburn K. Process evaluation of a digital health intervention for dementia caregivers: Integrating active and passive measurements. Alzheimers Dement. 2025 Sep;21(9):e70663. doi: 10.1002/alz.70663.
PubMed 40955511
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WECARE: A mHealth Intervention to Enhance Caregiving Mastery Among Chinese American Dementia Caregivers
- ClinicalTrials.gov ID
- NCT05992467
- Acronym / sponsor ID
- WECARE / George Mason University
- Conditions
- Caregiver Burden, Caregiver Stress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WECARE | Experimental | Behavioral: Wellness Enhancement for Caregivers (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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness Enhancement for Caregivers (WECARE)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. | Behavioural | WECARE |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40955511Shen K, Hong YA, Zhang YJ, Han HR, Lin J, Hepburn K. Process evaluation of a digital health intervention for dementia caregivers: Integrating active and passive measurements. Alzheimers Dement. 2025 Sep;21(9):e70663. doi: 10.1002/alz.70663.
- Individual participant dataSharing planned: Yes. Given the small sample size, we will not make individual participant data available to the public.
Related trials for Caregiver Burden
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The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
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Negotiation Training for Family Caregivers of People With Alzheimer's Disease
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Friends/Family of Individuals at Risk of Suicide Training Program
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VICA: A Virtual Care Assistant for Dementia Caregivers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Hong principal investigator
George Mason University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Enhancement for Caregivers (WECARE) in people with Caregiver Burden and Caregiver Stress Syndrome, run by George Mason University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.