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NCT05461495 · ClinicalTrials.gov registry record · NA

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

A NA study of Diabetes and Overweight, sponsored by New York University.

Active
Registry status
NA
Development phase
300
Enrollment target
1
Study location

NCT05461495 is a NA study of Diabetes and Overweight that is active but no longer recruiting, run by New York University. The registered enrollment target is 300 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05461495, a NA study of Diabetes and Overweight, is active but no longer recruiting, sponsored by New York University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
300 participants
Enrollment target
1
Study location

Study 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 decreas

Interventions

  • BEHAVIORAL Treatment Group

Study Locations (1)

New York

  • New York University - New York

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-02-01
Est. Completion 2026-06-30
Phase NA

Sponsor

New York University

83 total trials

What the Registry Record Tells You About NCT05461495

The ClinicalTrials.gov registry entry for NCT05461495 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (90% lower). The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Treatment Group is the first listed.

NCT05461495 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05461495 about?

NCT05461495 is a clinical study titled "NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers". 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...

What is the current status of trial NCT05461495?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2023-02-01. Estimated completion is 2026-06-30.

What conditions does trial NCT05461495 study?

This clinical trial studies the following conditions: Diabetes, Overweight, Heart Disease, Dementia Caregivers.

What interventions are being tested in trial NCT05461495?

The interventions under investigation include: Treatment Group (BEHAVIORAL).

Who is sponsoring clinical trial NCT05461495?

This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05461495 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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