ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05461495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * at least 50 years of age
  3. * self-identified as a primary caregiver
  4. * have access to Internet and phone with SMS and voice messaging
  5. * no plans to move for 12 months
  6. * able to read English, Chinese, or Korean
  7. * capable of completing informed consent
  8. * 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
  9. * care recipient regularly has trouble remembering recent events, repeat the same question over and over, or lose or misplace things
  1. * current alcoholic or substance abuse; and history of psychiatric diagnoses requiring hospitalization during the past 5 years

Contacts and Locations

Principal Investigator

Bei Wu, PhD
PRINCIPAL_INVESTIGATOR
New York University

Study Locations (Sites)

New York University
New York, New York, 10010
United States

Collaborators and Investigators

Sponsor: New York University

  • Bei Wu, PhD, PRINCIPAL_INVESTIGATOR, New York University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Dementia caregivers
  • Social support
  • depressive symptoms
  • physical health
  • Chinese American
  • Korean American

Additional Relevant MeSH Terms

  • Dementia Caregivers
  • Diabetes
  • Heart Disease
  • Overweight