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Completed

NCT Number: NCT05211869

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Young Adult

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T1D-CATCH

Behavioral

As defined by the Centers for Disease Control and Prevention (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.

Primary outcomes

  1. 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

  1. Technology Initiation

    Time frame: 3 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 use will be defined as at least 1 week of first use in the 3-month period. Variables will be described using summary statistics with counts/percentages.

  2. Continued Technology Use - Percent Use

    Time frame: 9 months following intervention

    Continued technology use by study end will be determined from device platform metrics detailing days/percent time used, in addition to self-report. Per standard diabetes technology clinical trial guidelines, CGM use is defined as pump use >90% time. The percentage of time used (% used) will be summarized by study arm using basic descriptive statistics. A target of at least 90% CGM wear-time is associated with the best outcomes for glycemic control.

  3. Continued Technology Use - Days of wear

    Time frame: 9 months following intervention

    Continued technology use by study end will be determined from device platform metrics detailing days/percent time used, in addition to self-report. Per standard diabetes technology clinical trial guidelines, CGM use is defined as ≥ 5/7 days wear over the 9 month period. Days of wear will be summarized study arm using basic descriptive statistics. A target of at least 5/7 days of CGM wear-time is associated with the best outcomes for glycemic control.

Other outcomes

  1. Feasibility Check

    Time frame: 6 months (post-intervention)

    Post-intervention interviews examining intervention content, complexity, comfort, delivery, and credibility

  2. Adoption

    Time frame: 9 months (post-intervention)

    Measured by recruitment logs

  3. Adoption

    Time frame: 9 months (post-intervention)

    Measured by electronic medical records (EMR)

  4. Adoption

    Time frame: 9 months (post-intervention)

    Measured by young adult participant consent rates

  5. Adoption

    Time frame: 9 months (post-intervention)

    Measured by percentage of provider opt-in

  6. Adoption

    Time frame: 9 months (post-intervention)

    Measured by CHW communications

  7. Fidelity

    Time frame: Baseline

    Measured by the community health worker (CHW) dashboard

  8. Fidelity

    Time frame: Baseline

    Measured by electronic medical records (EMR) to analyze session attendance

  9. Fidelity

    Time frame: Baseline

    Measured by content delivery

  10. Fidelity

    Time frame: 3 month mark

    Measured by community health workers (CHW) dashboard

  11. Fidelity

    Time frame: 3 month mark

    Measured by CHW session recordings

  12. Fidelity

    Time frame: 3 month mark

    Measured by EMR to analyze session attendance

  13. Fidelity

    Time frame: 3 month mark

    Measured by content delivery

  14. Fidelity

    Time frame: 3 month mark

    Measured by insurance tasks

  15. Fidelity

    Time frame: 6 month mark

    Measured by CHW dashboard

  16. Fidelity

    Time frame: 6 month mark

    Measured by CHW session recordings

  17. Fidelity

    Time frame: 6 month mark

    Measured by EMR to analyze session attendance

  18. Fidelity

    Time frame: 6 month mark

    Measured by content delivery

  19. Fidelity

    Time frame: 6 month mark

    Measured by insurance tasks

  20. Cost

    Time frame: 6 months (post-intervention)

    Measured by time sheets, receipts, and budget to analyze CHW salary/benefits

  21. Cost

    Time frame: 6 months (post-intervention)

    Measured by time sheets, receipts, and budget to analyze CHW equipment

  22. Cost

    Time frame: 6 months (post-intervention)

    Measured by time sheets, receipts, and budget to analyze CHW consumables

  23. YA-URM Autonomy/ Competence, Social Support

    Time frame: Baseline

    Measured using the Healthcare Self-Determination survey

  24. YA-URM Autonomy/ Competence, Social Support

    Time frame: 3 month mark

    Measured using the Healthcare Self-Determination survey

  25. YA-URM Autonomy/ Competence, Social Support

    Time frame: 6 month mark

    Measured using the Healthcare Self-Determination survey

  26. YA-URM Autonomy/ Competence, Social Support

    Time frame: 9 month mark

    Measured using the Healthcare Self-Determination survey

  27. Hemoglobin A1c

    Time frame: Baseline

    Obtained by POC (in clinic) or laboratory (DCA Vantage)

  28. Hemoglobin A1c

    Time frame: 3 month mark

    Obtained by POC (in clinic) or laboratory (DCA Vantage)

  29. Hemoglobin A1c

    Time frame: 6 month mark

    Obtained by POC (in clinic) or laboratory (DCA Vantage)

  30. Hemoglobin A1c

    Time frame: 9 month mark

    Obtained by POC (in clinic) or laboratory (DCA Vantage)

  31. Quality of Life (Diabetes Distress)

    Time frame: Baseline

    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)

  32. Quality of Life (Diabetes Distress)

    Time frame: Baseline

    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.

  33. Quality of Life (Diabetes Distress)

    Time frame: Baseline

    Validated survey: Diabetes Self-Management Questionnaire (DSMQ)

  34. Quality of Life (Diabetes Distress)

    Time frame: Baseline

    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.

  35. Quality of Life (Diabetes Distress)

    Time frame: 3 month follow-up

    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)

  36. Quality of Life (Diabetes Distress)

    Time frame: 3 month follow-up

    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.

  37. Quality of Life (Diabetes Distress)

    Time frame: 3 month follow-up

    Validated survey: Diabetes Self-Management Questionnaire (DSMQ)

  38. Quality of Life (Diabetes Distress)

    Time frame: 3 month follow-up

    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.

  39. Quality of Life (Diabetes Distress

    Time frame: 6 month follow-up

    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)

  40. Quality of Life (Diabetes Distress)

    Time frame: 6 month follow-up

    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.

  41. Quality of life (Diabetes Distress)

    Time frame: 6 month follow-up

    Validated survey: Diabetes Self-Management Questionnaire (DSMQ)

  42. Quality of Life (Diabetes Distress)

    Time frame: 6 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study 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)

Acronym: T1DTechCHW

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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