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OpenTrials
Completed

NCT Number: NCT03333044

Diabetes Management Intervention For South Asians

The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.

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Key information

Conditions

HbA1c Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

One Park Avenue

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • South Asian ethnicity (identified through a race and language code available in the EHR);
  • an appointment with a physician for routine non-emergent primary care in the last 12 months
  • diagnosis of diabetes
  • an HbA1c reading of >7 in the last 12 months

Exclusion criteria

  • Pregnant women and visits to obstetrician/gynecologist are excluded from the study

Treatment and study plan

Community Health Worker (CHW)-Led Health Coaching

Behavioral

CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.

EHR-Embedded Alerts

Other

An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.

Primary outcomes

  1. Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months

    Time frame: Baseline, Month 6

    Measured via complete lipoprotein panel.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2017
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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