Clinical trial NCT05461495: NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Official title: NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Caregivers
Diabetes
Heart Disease
Overweight
Keywords: Dementia caregivers
Social support
depressive symptoms
physical health
Chinese American
Korean American
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
name: Rutgers University
First posted: 2022-07-18
Enrollment: 300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 \[population social media app for Chinese/Korean\] 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: 12 months
measure: Self-rated Health
timeFrame: 12 months
measure: Caregiving related stress
timeFrame: 12 months
measure: Chronic disease self management behaviors
timeFrame: 12 months
measure: Diabetes
timeFrame: 12 months
measure: Hypertension
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Bei Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: