Testing a Diabetes Care Program in Rural and Low-Income Clinics

NCT07538505 | Not Yet Recruiting

• 1 other identifier: 25-0360
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate a Community Health Worker (CHW) program for people living with diabetes in rural areas or locations that are remote from the research team. The study aims to answer the following questions:

1. 1.Does the CHW program improve diabetes-related health outcomes, such as blood sugar control?
2. 2.What is the sustainability of the program?
3. 3.Is the program feasible and acceptable?

Conditions

Type 2 Diabetes Mellitus

Keywords

Community health workers; Type 2 diabetes mellitus; Rural; Hispanic; telehealth; mentor; low-income; implementation; education; access to care

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c)

  Change in glycemic control measured by hemoglobin A1c (HbA1c). HbA1c values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention HbA1c levels.

  baseline to 12 months

Secondary Outcomes (5)

• Change in Blood Pressure

  baseline to 12 months

• Change in Cholesterol Levels

  baseline to 12 months

• Change in Body Weight

  baseline to 12 months

• Change in Body Mass Index (BMI)

  baseline to 12 months

• Adherence to American Diabetes Association (ADA) Standards of Care

  baseline to 12 months

Study Arms (1)

CHW-led diabetes program

EXPERIMENTAL

Behavioral: Community Health Worker-led diabetes program

Interventions

Community Health Worker-led diabetes program BEHAVIORAL

The intervention consists of four phases: (1) clinic readiness assessment, (2) CHW training, (3) tele-mentoring CHWs to deliver the 12-month diabetes program, and (4) sustainability assessment through 36 months.

CHW-led diabetes program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified Hispanic Ethnicity
• Spanish-speaking
• Type 2 diabetes diagnosis, .g., physician documented diagnosis, HbA1c at least 6.5, treatment with a glucose-lowering agent

You may not qualify if:

• Condition known to alter HbA1c levels, e.g., recent transfusion, systemic steroids
• Severe mental illness or cognitive impairment that would preclude participation in group activities
• Pregnancy during the intervention period
• Type 1 diabetes mellitus

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Related Publications (8)

• Vaughan EM, Johnson E, Naik AD, Amspoker AB, Balasubramanyam A, Virani SS, Ballantyne CM, Johnston CA, Foreyt JP. Long-Term Effectiveness of the TIME Intervention to Improve Diabetes Outcomes in Low-Income Settings: a 2-Year Follow-Up. J Gen Intern Med. 2022 Sep;37(12):3062-3069. doi: 10.1007/s11606-021-07363-7. Epub 2022 Feb 7.

  PMID: 35132555 BACKGROUND

• Vaughan EM, Virani S, Al Rifai M, Cardenas VJ Jr, Johnston CA, Porterfield L, Santiago Delgado Z, Samson SL, Schick V, Naik AD. Determining call-to-entry rate and recruitment barriers in clinical studies for community clinics serving low-income populations: a cohort study. BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819.

  PMID: 37898484 BACKGROUND

• Vaughan EM, Cardenas VJ Jr, Chan W, Amspoker AB, Johnston CA, Virani SS, Ballantyne CM, Naik AD. Implementation and Evaluation of a mHealth-Based Community Health Worker Feedback Loop for Hispanics with and at Risk for Diabetes. J Gen Intern Med. 2024 Feb;39(2):229-238. doi: 10.1007/s11606-023-08434-7. Epub 2023 Oct 6.

  PMID: 37803098 BACKGROUND

• Vaughan EM, Naik AD, Amspoker AB, Johnston CA, Landrum JD, Balasubramanyam A, Virani SS, Ballantyne CM, Foreyt JP. Mentored implementation to initiate a diabetes program in an underserved community: a pilot study. BMJ Open Diabetes Res Care. 2021 Aug;9(1):e002320. doi: 10.1136/bmjdrc-2021-002320.

  PMID: 34385148 BACKGROUND

• Vaughan EM, Naik AD, Lewis CM, Foreyt JP, Samson SL, Hyman DJ. Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes. Telemed J E Health. 2020 Feb;26(2):244-250. doi: 10.1089/tmj.2018.0313. Epub 2019 Mar 6.

  PMID: 30839244 BACKGROUND

• Vaughan EM, Moreno JP, Hyman D, Chen TA, Foreyt JP. Efficacy of oral versus insulin therapy for newly diagnosed diabetes in low-income settings. Arch Gen Intern Med. 2017;1(2):17-22.

  PMID: 29517061 BACKGROUND

• Vaughan EM, Johnston CA, Cardenas VJ, Moreno JP, Foreyt JP. Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Diabetes Educ. 2017 Dec;43(6):589-599. doi: 10.1177/0145721717737742. Epub 2017 Oct 19.

  PMID: 29047326 BACKGROUND

• Vaughan EM, Hyman DJ, Naik AD, Samson SL, Razjouyan J, Foreyt JP. A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial. J Gen Intern Med. 2021 Feb;36(2):455-463. doi: 10.1007/s11606-020-06017-4. Epub 2020 Jul 22.

  PMID: 32700217 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth M. Vaughan, DO, MPH

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Lescano Ventura

CONTACT

409-772-2222; valescan@UTMB.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 20, 2026

Record last verified: 2026-04