Caregiver BurdenWECARE 3NCT07539350
WECARE: A Personalized Intervention for High-Demand Dementia Caregivers
A study testing WECARE and Equal-attention comparator in people with Caregiver Burden, run by George Mason University.
Trial summary
The goal of the project is to evaluate Wellness Enhancement for Caregivers (WECARE), a digital behavioral intervention for high-demand dementia caregivers. The behavioral intervention is culturally tailored to the target users and will be delivered via the WECARE mobile app and accompanying website, accessible only to… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- WECARE and Equal-attention comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently residing in the United States,
- are 21 years of age or older,
- own a smartphone or computer, AND
- currently care for a family member or loved one who lives of Alzheimer's disease or related dementia and meet one of hte following high-demand criteria:
- age 65 or older,
- provide 10 or more hours of direct care per week,
Show all 9Show fewer
- work 20 or more hours per week in addition to caregiving,
- care for another family member (e.g., a child under 18, another parent, or a spouse); or
- experience difficulty covering basic living expenses.
Who cannot join
- evidence or signs of severe cognitive impairment or mental disorders,
- the care recipient was receiving hospice care or had a life expectancy of fewer than six months, OR
- Unable to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of the project is to evaluate Wellness Enhancement for Caregivers (WECARE), a digital behavioral intervention for high-demand dementia caregivers. The behavioral intervention is culturally tailored to the target users and will be delivered via the WECARE mobile app and accompanying website, accessible only to verified enrolled participants. Participants will engage with digital learning materials and supportive resources over the course of the program. The goal is to determine whether this approach improves caregiver well-being and reduces stress related to caregiving.
- Conditions
- Caregiver Burden
- Being tested
- WECARE, Equal-attention comparator
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WECAREBehavioural
The 7-week WECARE intervention was designed to improve caregiving skills, alleviate caregiver distress, and enhance the psychosocial well-being of dementia caregivers. The program content includes short video clips, pictorial messages, and audio recordings tailored participants characteristics (e.g., caregiver role, baseline caregiving burden) and personalized to their individual needs based on weekly feedback.
Equal-attention comparatorBehavioural
Participants will access the the same WECARE app and accomanying website to receive the 7-week program featured in general health education. Each week, participants receive health information with a focused theme at the same frequency as the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will first complete a baseline survey online, then access the WECARE program via a project-specific mobile app (WECARE) or its accompanying website 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 the follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online. Receives: Behavioral: WECARE |
| Control Group | Active comparator | Participants in this arm will receive equal attention intervention. They will also access the WECARE app and accomanying website to receive the 7-week program featured in general health education. Each week, participants receive health information with a focused theme at the same frequency as the intervention group. Four weeks after the intervention or 11 weeks after the baseline, participants will complete the first follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online. Receives: Behavioral: Equal-attention comparator |
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 (1)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start2 Nov 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Y. Alicia Hong, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539350
- Sponsor's protocol ID
- MOD00001548
- Other IDs
- R01AG090610
- Acronym
- WECARE 3
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WECARE: A Personalized Intervention for High-Demand Dementia Caregivers
- ClinicalTrials.gov ID
- NCT07539350
- Acronym / sponsor ID
- WECARE 3 / MOD00001548
- Conditions
- Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the project is to evaluate Wellness Enhancement for Caregivers (WECARE), a digital behavioral intervention for high-demand dementia caregivers. The behavioral intervention is culturally tailored to the target users and will be delivered via the WECARE mobile app and accompanying website, accessible only to verified enrolled participants. Participants will engage with digital learning materials and supportive resources over the course of the program. The goal is to determine whether this approach improves caregiver well-being and reduces stress related to caregiving.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: WECAREParticipants will first complete a baseline survey online, then access the WECARE program via a project-specific mobile app (WECARE) or its accompanying website 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 the follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online. |
| Control Group | Active comparator | Behavioral: Equal-attention comparatorParticipants in this arm will receive equal attention intervention. They will also access the WECARE app and accomanying website to receive the 7-week program featured in general health education. Each week, participants receive health information with a focused theme at the same frequency as the intervention group. Four weeks after the intervention or 11 weeks after the baseline, participants will complete the first follow-up survey online. Six months after the baseline, participants will complete the second follow-up survey online. Tweleve months after the baseline, participants will complete the third follow-up survey online. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- currently residing in the United States,
- are 21 years of age or older,
- own a smartphone or computer, AND
- currently care for a family member or loved one who lives of Alzheimer's disease or related dementia and meet one of hte following high-demand criteria:
Key exclusion criteria (3 listed)
- evidence or signs of severe cognitive impairment or mental disorders,
- the care recipient was receiving hospice care or had a life expectancy of fewer than six months, 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 |
|---|---|---|
| WECAREThe 7-week WECARE intervention was designed to improve caregiving skills, alleviate caregiver distress, and enhance the psychosocial well-being of dementia caregivers. The program content includes short video clips, pictorial messages, and audio recordings tailored participants characteristics (e.g., caregiver role, baseline caregiving burden) and personalized to their individual needs based on weekly feedback. | Behavioural | Intervention group |
| Equal-attention comparatorParticipants will access the the same WECARE app and accomanying website to receive the 7-week program featured in general health education. Each week, participants receive health information with a focused theme at the same frequency as the intervention group. | Behavioural | Control Group |
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing WECARE and Equal-attention comparator in people with Caregiver Burden, run by George Mason University.
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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang Shen (7039931929, kshen2@gmu.edu), or a site near the patient. 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?
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 23 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.