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NCT Number: NCT07539350

WECARE: A Personalized Intervention for High-Demand Dementia Caregivers

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kang Shen

CONTACT

[email protected]

7039931929

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: WECARE 3

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 20, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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