NCT05992467

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

July 6, 2023

Last Update Submit

October 22, 2024

Conditions

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. Depressive symptoms will be measured by the CES-D, a 20-item survey instrument. The total score will be calculated to quantify depressive symptoms. The baseline and follow-up differences in the scores will be calculated.

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

Secondary Outcomes (2)

  • Efficacy of behavioral intervention in change from baseline in caregiving burden

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

  • Efficacy of behavioral intervention in change from baseline in life satisfaction

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

Other Outcomes (3)

  • Efficacy of behavioral intervention in change from baseline in caregiving mastery

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

  • Efficacy of behavioral intervention in change in care-recipient's problem behaviors

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention

  • Efficacy of behavioral intervention in change from baseline in positive aspect of caregiving

    Baseline (before the intervention) and follow-up (week 11-12, or 4-5 weeks after the intervention.

Study Arms (1)

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.

Behavioral: Wellness Enhancement for Caregivers (WECARE)

Interventions

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.

WECARE

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2023

First Posted

August 15, 2023

Study Start

September 1, 2023

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Given the small sample size, we will not make individual participant data available to the public.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the investigators completes primary data collection and the first report from this trial is accepted for publication.
Access Criteria
Researchers will submit a request including the purpose of accessing the data and a data user agreement

Locations