NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers

Diabetes Clinical Trial

Official title:

NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05461495
• Other study ID #: P50MD017356-8241
• Secondary ID: P50MD017356
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2023
• Source: New York University
• Contact: Yaolin Pei, PhD
• Phone: 212 992 5964
• Email: yp22[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 [population social media app for Chinese/Korean] 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) and inflammation (Oxidative stress, 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.

Description:

The physical and emotional demands of dementia caregiving can have enormous negative effects on caregivers' physical and mental health. Dementia caregivers have increased risk of hypertension and diabetes, compared to non-caregivers, especially in minority populations. The NYUCI has proven efficacy in reducing psychological outcomes among largely White samples of caregivers of persons with ADRD and has been widely replicated and translated in the USA and elsewhere. This study will provide the first large- scale test of the potential effects of the NYUCI-ES, a multicomponent intervention that includes individual and family counseling and ongoing support via support group and online chat groups and ad hoc (on demand) counseling.

Chinese American and Korean American dementia caregivers with multiple chronic conditions will be enrolled. This is an unblinded, randomized trial to assess the effectiveness of NYUCI intervention among Chinese and Korean American dementia caregivers. The study will utilize quantitative methods to learn more about the physical health and psychological health outcomes in Chinese and Korean American dementia caregivers.

This study lasts 1 year. The intervention will include two group with each ethnicity group. All participants will participate an on-line chat group and call the counselor for resource information and support as needed. Participants in the treatment group will receive 6 counseling sessions an participate in local support group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years.

Related Conditions & MeSH terms

• Dementia
• Dementia Caregivers
• Diabetes
• Heart Disease
• Heart Diseases
• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University	NYU Langone Health, Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Self-rated Health	This measure includes three global self-rated physical health items from the OARS battery of questionnaires (ICC = 0.83) to assess subjective evaluation of health. The sum of the 3 questions is used to measure SRH	12 months
Primary	Caregiving related stress	It will be measured by the severity of reaction axis of the Revised Memory and Behavior Problems Checklist.	12 months
Primary	Chronic disease self management behaviors	It will be measured with the Summary of Diabetes Self-Care Activities Measure,98 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
Primary	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.	12 months
Primary	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
Primary	BMI	Body Mass Index (BMI) will be measured through height and weight measurements. A digital scale and stadiometer will be used to measure height and weight and calculate BMI. Body Mass Index > 23 kg/m2 will be used to determine obesity.	12 months