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

Study Overview
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Brief Summary
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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 toT1D-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
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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.

Official Title
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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)

Conditions
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Diabetes, Type 1 Diabetes, Young Adult, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: T1D-CATCH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: T1D duration ≥6 months 18-30 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 9-month randomized controlled trial in which YA-URMs will be randomized to T1D-CATCH or usual care
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T1D-CATCH<br>The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules. | Behavioral: T1D-CATCH<br>* As defined by the CDC, a CHW is a frontline public health worker who is a trusted member of a community or who has a thorough understanding of the community being served, and leverages this unique position to link health systems, social services, and communities. CHWs engender trust with patients by having direct community and lived experience, offering specific support and empathy that may be difficult for other diabetes care professionals to provide. In addition, CHWs have firsthand understanding of cultural barriers to traditional western healthcare and can promote patient-centered culturally-relevant care. They enhance team-based care by helping providers with extra outreach, social needs management, time-consuming tasks, and aligning patient-provider priorities. CHWs in this project will provide social needs assessment and management, introduction to diabetes technologies, and support for onboarding to technology.<br>|
| No Intervention: Usual Care Control Condition<br>Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technology Use | 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) | 9 month mark | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YA-URM Autonomy/ Competence, Social Support | Measured using the Healthcare Self-Determination survey | Baseline | 
| YA-URM Autonomy/ Competence, Social Support | Measured using the Healthcare Self-Determination survey | 3 month mark | 
| YA-URM Autonomy/ Competence, Social Support | Measured using the Healthcare Self-Determination survey | 6 month mark | 
| YA-URM Autonomy/ Competence, Social Support | Measured using the Healthcare Self-Determination survey | 9 month mark | 
| Hemoglobin A1c | Obtained by POC (in clinic) or laboratory (DCA Vantage) | Baseline | 
| Hemoglobin A1c | Obtained by POC (in clinic) or laboratory (DCA Vantage) | 3 month mark | 
| Hemoglobin A1c | Obtained by POC (in clinic) or laboratory (DCA Vantage) | 6 month mark | 
| Hemoglobin A1c | Obtained by POC (in clinic) or laboratory (DCA Vantage) | 9 month mark | 
| Quality of Life (Diabetes Distress) | Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true) | Baseline | 
| Quality of Life (Diabetes Distress) | Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire. | Baseline | 
| Quality of Life (Diabetes Distress) | Validated survey: Diabetes Self-Management Questionnaire (DSMQ) | Baseline | 
| Quality of Life (Diabetes Distress) | Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support. | Baseline | 
| Quality of Life (Diabetes Distress) | Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true) | 3 month follow-up | 
| Quality of Life (Diabetes Distress) | Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire. | 3 month follow-up | 
| Quality of Life (Diabetes Distress) | Validated survey: Diabetes Self-Management Questionnaire (DSMQ) | 3 month follow-up | 
| Quality of Life (Diabetes Distress) | Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support. | 3 month follow-up | 
| Quality of Life (Diabetes Distress | Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true) | 6 month follow-up | 
| Quality of Life (Diabetes Distress) | Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire. | 6 month follow-up | 
| Quality of life (Diabetes Distress) | Validated survey: Diabetes Self-Management Questionnaire (DSMQ) | 6 month follow-up | 
| Quality of Life (Diabetes Distress) | Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support. | 6 month follow-up | 
| Technology Use | 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) | 3 month mark | 
| Technology Use | 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) | 6 month mark | 
| Technology Use | 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) | 9 month mark |