NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
2 other identifiers
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
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
May 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
October 15, 2025
August 1, 2025
3.4 years
May 18, 2022
October 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Depressive symptoms
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire-9 (PHQ-9),because of its brevity, well-validated reliable measures, that has been used in other studies of Chinese and Korean adults.
12 months
Self-rated Health
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.
12 months
Caregiving related stress
It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.
12 months
Chronic disease self management behaviors
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, testing blood sugar, foot care, and smoking.
12 months
Social support
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.
12 months
Diabetes
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.
12 months
Lipid metabolism
Triglycerides, Cholesterol, HDL, LDL, and VLDL will be measured along with HbA1c using the same method. Low-density lipoprotein (LDL) \> 130 mg/dL or total cholesterol \> 200 mg/dL will be used to determine high cholesterol.
12 months
Hypertension
Blood pressure will be measured utilizing PhenX Toolkit recommended procedures and OMRON automated blood pressure machine. A cut-off of systolic blood pressure (SBP) \>= 130 mmHg or diastolic blood pressure (DBP) \>= 80mmHg will be used to determine the presence of hypertension
12 months
Waist circumferences and Body Mass index (BMI)
Waist circumference will be measured using a flexible, non-stretchable measuring tape at the halfway point between the lower margin of the last palpable rib and the top of the hip bone. BMI will be measured through height (feet/inches or cm) and weight (lb or kg) measurements. A digital scale and stadiometer will be used to measure height and weight. Weight and height will be combined to report Body Mass Index in \> 23 kg/m2 will be used to determine obesity.
12 months
Study Arms (2)
Treatment Group
EXPERIMENTALTreatment group will receive 6 counseling sessions, participate in local support group and on-line chat group, and receive "ad hoc" counseling.
Control Group
NO INTERVENTIONControl group will participate in on-line chat group, and call the counselor for resource information and support as needed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- A spouse or other family caregiver of Chinese or Korean ancestry living in New York City or Bergen County New Jersey, who is willing to participate in the study (additional family members can be included in family counseling sessions if the CG is assigned to the treatment group)
- at least 50 years of age
- self-identified as a primary caregiver
- have access to Internet and phone with SMS and voice messaging
- no plans to move for 12 months
- able to read English, Chinese, or Korean
- capable of completing informed consent
- meet specific cardiometabolic and depressive symptom criteria: Cardiometabolic syndrome: It will not be required to submit objective measurement of cardiometabolic disorder, self-reported medical conditions will be accepted for enrollment. Diabetes: self-reported OR A1C \>= 5.7% OR High Cholesterol: self-reported OR low-density lipoprotein (LDL) \> 130 mg/dL or total cholesterol \> 200 mg/dL (American Heart Association 2018) OR Hypertension: self-reported OR systolic blood pressure (SBP) \>= 130 mmHg or diastolic blood pressure (DBP) \>= 80mmHg (2017 ACC/AHA hypertension guideline) OR Body Mass Index \> 23 kg/m2 by self-reported or measured height and weight (WHO expert consultation regarding Asian cut-off) OR other related metabolic syndrome, such as euthyroid hypothyroxinemia
- care recipient regularly has trouble remembering recent events, repeat the same question over and over, or lose or misplace things
You may not qualify if:
- current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New York Universitylead
- NYU Langone Healthcollaborator
- Rutgers Universitycollaborator
Study Sites (1)
New York University
New York, New York, 10010, United States
Related Publications (1)
Wang J, Leong IT, Johnson MK, Pei Y, Lee KH, Mittelman MS, Epstein C, Cho S, Wu B. What Matters to Chinese and Korean American Dementia Caregivers: Navigating Cultural Influences in Dementia Care from Caregivers' Perspectives. J Alzheimers Dis. 2024;98(2):519-538. doi: 10.3233/JAD-231140.
PMID: 38427483BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bei Wu, PhD
New York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2022
First Posted
July 18, 2022
Study Start
February 1, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Data will be made available at Clinicaltrials.gov and ICPSR (a specific link will be provided after the study is published/when the DOI is obtained).
The de-identified individual participant data collected during the trial will be shared between 9 months and 36 months following article publication or as required by a condition of awards and agreements supporting the research, for researchers who provide a methodologically sound proposal. Data will be made available at https://www.icpsr.umich.edu/web/pages (Note: a specific link will be provided after the study is published/when the DOI is obtained.) The protocol, statistical analysis plan, and analytic code will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.