T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups

Not Applicable

Active, not recruiting

• Conditions: Diabetes; Type 1 Diabetes; Diabetes Mellitus; Young Adult

• Registration Number: NCT05211869
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care. The investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.

Detailed Description

The study will involve a 9-month randomized control trial of usual care versus T1D-CATCH, an intervention that enhances core community health worker (CHW) service roles to support increased use of T1D technology in young adults (underrepresented minorities)(YA_URM's). Participants will be recruited from primary and specialty care practices at Montefiore Medical Center in the Bronx, NY, which is a large safety-net hospital system in one of the poorest counties in the U.S. Two young adult-aged CHWs from the Montefiore CHW program will be trained extensively per our Supporting Emerging Adults with Diabetes (SEAD) program manuals. For YA-URMs, CHWs will conduct hands-on diabetes technology education, goal-setting, peer support, and social service linkage. CHWs will also help shift insurance approval tasks away from busy providers and better align patient-provider priorities through close communication between the YA-URM and provider. Group sessions will be optional and will follow the YA-centric education curriculum developed in Dr. Agarwal's Supporting Emerging Adults with Diabetes (SEAD) program.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Study Start: 2022-11-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• T1D duration ≥6 months
• 18-35 years old
• Self-identified URM status: non-Hispanic Black or Hispanic
• English- or Spanish-speaking
• Not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology)

Exclusion Criteria

• Developmental or sensory disability interfering with study participation
• Current pregnancy
• Participation in another behavioral or diabetes technology intervention study in the past 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Technology Use	9 month mark	Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)

Secondary Outcome Measures

Name	Time	Method
Technology Use	9 month mark	Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States