Diabetes Management Intervention For South Asians

Not Applicable

Completed

• Conditions: HbA1c; Diabetes
• Interventions: Behavioral: HIT-enabled; Behavioral: Community Health Worker (CHW)-led health; Behavioral: Physician enabled care coordination

• Registration Number: NCT03333044
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2019-07-11
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 859

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HIT-enabled & CHW led	HIT-enabled	Supportive care enabled by mobile devices.
CHW & Physician Feedback	Physician enabled care coordination	Patient setting progress communicated to physician via PHI
CHW-led health coaching	Community Health Worker (CHW)-led health	Group sessions
CHW & Physician Feedback	Community Health Worker (CHW)-led health	Patient setting progress communicated to physician via PHI

Primary Outcome Measures

Name	Time	Method
Average change in hemoglobin A1c test (HbA1c)	Baseline, Month 6	Measured via complete lipoprotein panel.

Secondary Outcome Measures

Name	Time	Method
Referrals to community services	Up to Month 6	Number of referrals given to community service over the course of 6 months.
Change in Diabetes Self-Efficacy Score	Baseline, Month 6	Diabetes self-efficacy is measured using 4 questions rated on a scale from 1 (none of the time) to 5 (all of the time). The total score is the sum of responses and ranges from 4 to 20. Higher scores indicate greater diabetes self-efficacy.

Trial Locations

Locations (1)

One Park Avenue; 🇺🇸 New York, New York, United States