WECARE: A Personalized Intervention for High-Demand Dementia Caregivers

NCT07539350 | Not Yet Recruiting DMC

• 2 other identifiers: MOD00001548R01AG090610
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)

Other Outcomes (4)

• Efficacy of Behavioral Intervention in Change From Baseline in Life Satisfaction

  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

  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

  Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)

Study Arms (2)

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.

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.

Behavioral: Equal-attention comparator

Interventions

WECARE BEHAVIORAL

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.

Intervention group

Equal-attention comparator BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• George Mason University: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Kang Shen

CONTACT

7039931929; kshen2@gmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share