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

Diabetes Clinical Trial

— T1DTechCHW  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211869
• Other study ID #: 2021-13714
• Secondary ID: R01DK132302
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Albert Einstein College of Medicine
• Contact: Shivani Agarwal, MD, MPH
• Phone: 844-556-6683
• Email: shivani.agarwal[@]einsteinmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Young Adult

Intervention

Behavioral:
• T1D-CATCH
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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (24)

Addala A, Auzanneau M, Miller K, Maier W, Foster N, Kapellen T, Walker A, Rosenbauer J, Maahs DM, Holl RW. A Decade of Disparities in Diabetes Technology Use and HbA1c in Pediatric Type 1 Diabetes: A Transatlantic Comparison. Diabetes Care. 2021 Jan;44(1):133-140. doi: 10.2337/dc20-0257. Epub 2020 Sep 16. — View Citation

Addala A, Hanes S, Naranjo D, Maahs DM, Hood KK. Provider Implicit Bias Impacts Pediatric Type 1 Diabetes Technology Recommendations in the United States: Findings from The Gatekeeper Study. J Diabetes Sci Technol. 2021 Sep;15(5):1027-1033. doi: 10.1177/19322968211006476. Epub 2021 Apr 15. — View Citation

Agarwal S, Crespo-Ramos G, Long JA, Miller VA. "I Didn't Really Have a Choice": Qualitative Analysis of Racial-Ethnic Disparities in Diabetes Technology Use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):616-622. doi: 10.1089/dia.2021.0075. — View Citation

Agarwal S, Schechter C, Gonzalez J, Long JA. Racial-Ethnic Disparities in Diabetes Technology use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Apr;23(4):306-313. doi: 10.1089/dia.2020.0338. Epub 2020 Dec 1. — View Citation

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C3 Project. The Community Health Worker Core Consensus Project (C3): Roles and Competencies. C3 Project Findings. Published 2018. Accessed April 29, 2021. https://www.c3project.org/roles-competencies

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Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18. Erratum In: Diabetes Technol Ther. 2019 Apr;21(4):230. — View Citation

Franklin CM, Bernhardt JM, Lopez RP, Long-Middleton ER, Davis S. Interprofessional Teamwork and Collaboration Between Community Health Workers and Healthcare Teams: An Integrative Review. Health Serv Res Manag Epidemiol. 2015 Mar 16;2:2333392815573312. doi: 10.1177/2333392815573312. eCollection 2015 Jan-Dec. — View Citation

Hagiwara N, Elston Lafata J, Mezuk B, Vrana SR, Fetters MD. Detecting implicit racial bias in provider communication behaviors to reduce disparities in healthcare: Challenges, solutions, and future directions for provider communication training. Patient Educ Couns. 2019 Sep;102(9):1738-1743. doi: 10.1016/j.pec.2019.04.023. Epub 2019 Apr 19. — View Citation

Hall WJ, Chapman MV, Lee KM, Merino YM, Thomas TW, Payne BK, Eng E, Day SH, Coyne-Beasley T. Implicit Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. Am J Public Health. 2015 Dec;105(12):e60-76. doi: 10.2105/AJPH.2015.302903. Epub 2015 Oct 15. — View Citation

Lai CW, Lipman TH, Willi SM, Hawkes CP. Racial and Ethnic Disparities in Rates of Continuous IRB NUMBER: 2021-13714 IRB APPROVAL DATE: 03/23/2022 Glucose Monitor Initiation and Continued Use in Children With Type 1 Diabetes. 2020;(Online ahead of print). doi:10.2337/dc20-1663

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Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27. — View Citation

Walker AF, Hood KK, Gurka MJ, Filipp SL, Anez-Zabala C, Cuttriss N, Haller MJ, Roque X, Naranjo D, Aulisio G, Addala A, Konopack J, Westen S, Yabut K, Mercado E, Look S, Fitzgerald B, Maizel J, Maahs DM. Barriers to Technology Use and Endocrinology Care for Underserved Communities With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1480-1490. doi: 10.2337/dc20-2753. Epub 2021 May 17. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility Check	Post-intervention interviews examining intervention content, complexity, comfort, delivery, and credibility	6 months (post-intervention)
Other	Adoption	Measured by recruitment logs	9 months (post-intervention)
Other	Adoption	Measured by electronic medical records (EMR)	9 months (post-intervention)
Other	Adoption	Measured by young adult participant consent rates	9 months (post-intervention)
Other	Adoption	Measured by percentage of provider opt-in	9 months (post-intervention)
Other	Adoption	Measured by CHW communications	9 months (post-intervention)
Other	Fidelity	Measured by the community health worker (CHW) dashboard	Baseline
Other	Fidelity	Measured by electronic medical records (EMR) to analyze session attendance	Baseline
Other	Fidelity	Measured by content delivery	Baseline
Other	Fidelity	Measured by community health workers (CHW) dashboard	3 month mark
Other	Fidelity	Measured by CHW session recordings	3 month mark
Other	Fidelity	Measured by EMR to analyze session attendance	3 month mark
Other	Fidelity	Measured by content delivery	3 month mark
Other	Fidelity	Measured by insurance tasks	3 month mark
Other	Fidelity	Measured by CHW dashboard	6 month mark
Other	Fidelity	Measured by CHW session recordings	6 month mark
Other	Fidelity	Measured by EMR to analyze session attendance	6 month mark
Other	Fidelity	Measured by content delivery	6 month mark
Other	Fidelity	Measured by insurance tasks	6 month mark
Other	Cost	Measured by time sheets, receipts, and budget to analyze CHW salary/benefits	6 months (post-intervention)
Other	Cost	Measured by time sheets, receipts, and budget to analyze CHW equipment	6 months (post-intervention)
Other	Cost	Measured by time sheets, receipts, and budget to analyze CHW consumables	6 months (post-intervention)
Primary	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	YA-URM Autonomy/ Competence, Social Support	Measured using the Healthcare Self-Determination survey	Baseline
Secondary	YA-URM Autonomy/ Competence, Social Support	Measured using the Healthcare Self-Determination survey	3 month mark
Secondary	YA-URM Autonomy/ Competence, Social Support	Measured using the Healthcare Self-Determination survey	6 month mark
Secondary	YA-URM Autonomy/ Competence, Social Support	Measured using the Healthcare Self-Determination survey	9 month mark
Secondary	Hemoglobin A1c	Obtained by POC (in clinic) or laboratory (DCA Vantage)	Baseline
Secondary	Hemoglobin A1c	Obtained by POC (in clinic) or laboratory (DCA Vantage)	3 month mark
Secondary	Hemoglobin A1c	Obtained by POC (in clinic) or laboratory (DCA Vantage)	6 month mark
Secondary	Hemoglobin A1c	Obtained by POC (in clinic) or laboratory (DCA Vantage)	9 month mark
Secondary	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
Secondary	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
Secondary	Quality of Life (Diabetes Distress)	Validated survey: Diabetes Self-Management Questionnaire (DSMQ)	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Life (Diabetes Distress)	Validated survey: Diabetes Self-Management Questionnaire (DSMQ)	3 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of life (Diabetes Distress)	Validated survey: Diabetes Self-Management Questionnaire (DSMQ)	6 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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