Clinical trial
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05461495
What this study is about
This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk/other social media apps \[popular social media apps for individuals of Chinese or Korean descents\] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin, BMI) and inflammation (hsCRP, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life.
Basic eligibility
Full registry criteria
Treatments and study arms
Treatment Group
This intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in Chinese and Korean American dementia caregivers has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is participation in an on-line chat group to provide peer support. The fourth component of the treatment is "ad hoc" counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease.
Primary outcomes
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire-9 (score range: 0-27; higher scores mean more depressive symptoms), because of its brevity, well-validated reliable measures, that has been used in other studies of Chinese and Korean adults.
This measure includes three global self-rated physical health items from the Older Americans Resources and Services (OARS) battery of questionnaires (ICC = 0.83) to assess subjective evaluation of health. The sum of the 3 questions is used to measure self-rated health.
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
The 9-item Positive Aspects of Caregiving Scale will be used to measure positive aspects of caregiving, indicating that higher scores mean more positive caregiving experiences (score range: 9-45).
Stigma will be measured using the 12-item Affiliated Stigma Scale, with higher scores indicating greater affiliate stigma (score range: 12-84).
It will be measured with the Summary of Diabetes Self-Care Activities Measure, which is widely used by diabetes researchers and assesses frequency of healthy eating (e.g., how many of the last seven days did you eat five or more servings of fruits and vegetables), exercise/physical activity (5-item Simple Physical Activity Questionnaire), testing blood sugar, foot care. Sleep hours and quality, smoking, alcohol consumption, and encounters with health providers will also be measured.
The following measures will be used to assess various aspects of social support. Subjective social support will be measured using the Lubben Social Network Scale-6-item version. The Social Support Availability Scale will be used to evaluate the availability of emotional, instrumental, and informational support. The use of formal support services, such as respite care, support groups, and home health care aids, will be assessed with the Service Utilization Scale. Additionally, the WeChat Use Intensity Questionnaire (WUIQ) will be used to measure the use of social media applications, and it will be adapted to include KakaoTalk and other platforms.
HbA1C will be measured through a fingerstick and processed in the Bayer A1CNow® device, which is National Glycohemoglobin Standardization Program Certified and has demonstrated accuracy and precision. A cut-off of HbA1C \>= 5.7% will be used to determine pre-diabetic status.
Study locations
1 locations were listed when this page was built. The first 40 are shown.