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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05992467
Other study ID # George Mason University
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date August 31, 2024

Study information

Verified date May 2024
Source George Mason University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators propose to test a culturally tailored mHealth behavioral intervention to enhance caregiving mastery and improve psychosocial wellbeing among Chinese American family caregivers of persons living with Alzheimer's Disease and related dementia. This intervention, Wellness Enhancement for Caregivers (WECARE), will be delivered via WeChat, a social media app highly popular among Chinese Americans. About 45 participants will be recruited for the pilot test. Participants will complete a baseline survey, receive 7-week WECARE program on their WeChat accounts, complete a follow-up survey 12 weeks after the baseline, and then a qualitative interview on Zoom.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 90 Years
Eligibility Inclusion Criteria: 1. 21 years or older, 2. self-identified as Chinese or Chinese American, 3. speak and read Chinese (Mandarin or Cantonese), 4. own a smartphone and use WeChat, 5. living in Washington DC metropolitan, and 6. currently care for a family member with ADRD and provide care for at least 10 hours a week. Exclusion Criteria: 1. do not read or speak Chinese, 2. care-recipient is in hospice care or have a life expectancy less than 6 months, 3. signs of severe intellectual deficits or psychotic disorders, or 4. unable to provide informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wellness Enhancement for Caregivers (WECARE)
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.

Locations

Country Name City State
United States George Mason University Fairfax Virginia

Sponsors (1)

Lead Sponsor Collaborator
George Mason University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Efficacy of behavioral intervention in change from baseline in caregiving mastery The baseline and follow-up differences in caregiving mastery will be assessed. Caregiving mastery will be measured by the Caregiving Mastery Scale, a 7-item survey instrument. The total score will be calculated to quantify caregiving mastery. 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
Other Efficacy of behavioral intervention in change in care-recipient's problem behaviors The baseline and follow-up differences in care-recipient's problem behaviors will be assessed. Care-recipient's problem behaviors will be measured by a list of 20-item problem behaviors. The total score will be calculated to quantify the number of problem behaviors. 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
Primary 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 Efficacy of behavioral intervention in change from baseline in caregiving burden The baseline and follow-up differences in caregiving burden will be assessed. Caregiving burden will be measured by the Zarit Burden Interview, a 12-item survey instrument. The total score will be calculated to quantify caregiving burden. 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 Efficacy of behavioral intervention in change from baseline in life satisfaction The baseline and follow-up differences in life satisfaction will be assessed. Life satisfaction will be measured by the Life Satisfaction Scale, a 5-item survey instrument. The total score will be calculated to quantify life satisfaction. 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
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