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WECARE: A Personalized Intervention for High-Demand Dementia Caregivers

ConditionCaregiver Burden
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-100
SponsorGeorge Mason University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

currently residing in the United States,

are 21 years of age or older,

own a smartphone or computer, AND

age 65 or older,

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
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.

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

Other outcomes

1

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.

Time frame
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
2

Efficacy of Behavioral Intervention in Change From Baseline in Caregiving Mastery

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.

Time frame
Baseline, and Follow-Up at Weeks 11-12 (4 to 5 weeks after completion of the intervention)
3

Efficacy of Behavioral Intervention in Change in Care-recipient's Problem Behaviors

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.

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

Efficacy of Behavioral Intervention in Change From Baseline in Positive Aspect of Caregiving

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.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Mason University

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

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