Clinical trial NCT05211869: T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
Type 1 Diabetes
Young Adult
Diabetes Mellitus
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2022-01-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Technology Use
timeFrame: 9 month mark
Secondary outcomes:
measure: Technology Use
timeFrame: 3 month mark
measure: Technology Use
timeFrame: 6 month mark
measure: Technology Use
timeFrame: 9 month mark
Other outcomes:
measure: Feasibility Check
timeFrame: 6 months (post-intervention)
measure: Adoption
timeFrame: 9 months (post-intervention)
measure: Adoption
timeFrame: 9 months (post-intervention)
measure: Adoption
timeFrame: 9 months (post-intervention)
measure: Adoption
timeFrame: 9 months (post-intervention)
measure: Adoption
timeFrame: 9 months (post-intervention)
measure: Fidelity
timeFrame: Baseline
measure: Fidelity
timeFrame: Baseline
measure: Fidelity
timeFrame: Baseline
measure: Fidelity
timeFrame: 3 month mark
measure: Fidelity
timeFrame: 3 month mark
measure: Fidelity
timeFrame: 3 month mark
measure: Fidelity
timeFrame: 3 month mark
measure: Fidelity
timeFrame: 3 month mark
measure: Fidelity
timeFrame: 6 month mark
measure: Fidelity
timeFrame: 6 month mark
measure: Fidelity
timeFrame: 6 month mark
measure: Fidelity
timeFrame: 6 month mark
measure: Fidelity
timeFrame: 6 month mark
measure: Cost
timeFrame: 6 months (post-intervention)
measure: Cost
timeFrame: 6 months (post-intervention)
measure: Cost
timeFrame: 6 months (post-intervention)
measure: YA-URM Autonomy/ Competence, Social Support
timeFrame: Baseline
measure: YA-URM Autonomy/ Competence, Social Support
timeFrame: 3 month mark
measure: YA-URM Autonomy/ Competence, Social Support
timeFrame: 6 month mark
measure: YA-URM Autonomy/ Competence, Social Support
timeFrame: 9 month mark
measure: Hemoglobin A1c
timeFrame: Baseline
measure: Hemoglobin A1c
timeFrame: 3 month mark
measure: Hemoglobin A1c
timeFrame: 6 month mark
measure: Hemoglobin A1c
timeFrame: 9 month mark
measure: Quality of Life (Diabetes Distress)
timeFrame: Baseline
measure: Quality of Life (Diabetes Distress)
timeFrame: Baseline
measure: Quality of Life (Diabetes Distress)
timeFrame: Baseline
measure: Quality of Life (Diabetes Distress)
timeFrame: Baseline
measure: Quality of Life (Diabetes Distress)
timeFrame: 3 month follow-up
measure: Quality of Life (Diabetes Distress)
timeFrame: 3 month follow-up
measure: Quality of Life (Diabetes Distress)
timeFrame: 3 month follow-up
measure: Quality of Life (Diabetes Distress)
timeFrame: 3 month follow-up
measure: Quality of Life (Diabetes Distress
timeFrame: 6 month follow-up
measure: Quality of Life (Diabetes Distress)
timeFrame: 6 month follow-up
measure: Quality of life (Diabetes Distress)
timeFrame: 6 month follow-up
measure: Quality of Life (Diabetes Distress)
timeFrame: 6 month follow-up
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Shivani Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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