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Clinical Trials/NCT05211869
NCT05211869
Completed
N/A

T1DTechCHW: Enhancing the Community Health Worker (CHW) Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups (YA-URMs) With Type 1 Diabetes (T1D)

Albert Einstein College of Medicine1 site in 1 country119 target enrollmentNovember 7, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Albert Einstein College of Medicine
Enrollment
119
Locations
1
Primary Endpoint
Technology Initiation
Status
Completed
Last Updated
3 months ago

Overview

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, New York, 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.

Registry
clinicaltrials.gov
Start Date
November 7, 2022
End Date
December 8, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Technology Initiation

Time Frame: 6 months following intervention

Technology use will be tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured and reported as a binary variable (yes/no). Technology will include any combination of continuous glucose monitor (CGM), pump, or CGM and pump. Technology initiation will be defined as at least 1 week of first use in the 6-month period. Variables will be described using summary statistics with counts/percentages.

Secondary Outcomes

  • Technology Initiation(3 months following intervention)
  • Continued Technology Use - Percent Use(9 months following intervention)
  • Continued Technology Use - Days of wear(9 months following intervention)

Study Sites (1)

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