- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550075
Caring for Dementia Caregivers in Ethnic Immigrant Communities
Many caregivers of people with Alzheimer's disease or other dementias-especially those in immigrant communities who don't speak English well-don't get access to helpful, proven support programs. This is especially true for Korean American caregivers.
To address this, the investigative team adapted an existing caregiver support program (called the Savvy Caregiver Program) to better fit Korean culture and language. This new version, called K-Savvy, is a 6-week online program taught in Korean. In an earlier small study, K-Savvy worked well: caregivers found it helpful, were willing to use it, and showed fewer symptoms of depression.
Now, the investigative team wants to study it more carefully to see how well it really works and why.
The study has two main goals:
Goal 1:
The investigative team will measure whether K-Savvy improves caregivers' well-being-specifically whether it reduces stress and depression and helps them feel more positive about caregiving. The investigative team will also look at why it works, focusing on whether it changes how caregivers think about their situation (for example, feeling less overwhelmed and more confident).
Goal 2:
The investigative team will talk directly with caregivers and program instructors to understand their experiences with K-Savvy. This will help the investigative team learn what worked well, what didn't, and why.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuri Jang, PhD
- Phone Number: 213-821-6441
- Email: yurij@usc.edu
Study Contact Backup
- Name: Min-Kyoung Rhee, PhD
- Phone Number: 213-740-1725
- Email: minkyour@usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90089
- University of Southern California
-
Contact:
- Yuri Jang, PhD
- Phone Number: 213-821-6441
- Email: yurij@usc.edu
-
Contact:
- Min-Kyoung Rhee, PhD
- Phone Number: 213-740-1725
- Email: minkyour@usc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Self-identified Korean American adults aged 18 or older Provide care for a family member with dementia as a primary caregiver Primary caregiver defined as providing a minimum of 10 hours per week of in-home caregiving to a family member Speak English less than "very well" Able to attend virtual classes using an electronic device with Internet access
Exclusion Criteria:
Individuals with severe depression (Patient Health Questionnaire [PHQ-9] score ≥ 20), as K-Savvy is not a mental health treatment program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: K-Savvy
immediate enrollment in K-Savvy, 6-week online psychoeducation program
|
Funded by the NIA (R21AG071790, PI: Jang), our team successfully completed linguistic and cultural adaptations of the Savvy Caregiver Program (SCP) for Korean American dementia caregivers with limited English Proficiency.
The Korean version of the SCP (K-Savvy) has shown high feasibility, acceptability, and initial efficacy.
|
|
Active Comparator: Healthy Living
enrollment in a 6-week online health education program and subsequent enrollment in K-Savvy
|
Funded by the NIA (R21AG071790, PI: Jang), our team successfully completed linguistic and cultural adaptations of the Savvy Caregiver Program (SCP) for Korean American dementia caregivers with limited English Proficiency.
The Korean version of the SCP (K-Savvy) has shown high feasibility, acceptability, and initial efficacy.
6-week online health education for Korean Americans with limited English proficiency
|
|
Other: waitlist control
K-Savvy enrollment after a waiting period
|
Funded by the NIA (R21AG071790, PI: Jang), our team successfully completed linguistic and cultural adaptations of the Savvy Caregiver Program (SCP) for Korean American dementia caregivers with limited English Proficiency.
The Korean version of the SCP (K-Savvy) has shown high feasibility, acceptability, and initial efficacy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depressive symptoms
Time Frame: from enrollment to 6-month follow-up
|
symptoms of depression assessed with Patient Health Questionnaire-9, range from 0 to 27 (higher scores indicating greater depressive symptoms)
|
from enrollment to 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
caregiver burden
Time Frame: from enrollment to 6-month follow-up
|
the level of stress and burden measures with the Zarit's Caregiver Burden Scale, range from 0 to 48 (higher scores indicating greater sense of burden)
|
from enrollment to 6-month follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01AG090561 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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