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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:
Participants will be invited to attend monthly diabetes education classes led by CHWs and receive weekly mobile health check-ins from CHWs for coaching and to help coordinate care with their clinic team.
Background:
Type 2 diabetes disproportionately affects low-income and Hispanic populations, who face barriers such as limited literacy, poverty, and lack of insurance. Prevalence is projected to rise, worsening disparities and increasing healthcare costs. Community Health Workers (CHWs) have been shown to improve diabetes outcomes by bridging patients and healthcare systems. Tele-mentoring CHWs allows interventions to be scaled geographically, but effectiveness in real-world clinics remains to be evaluated.
Objective & Aims:
This 12-month, single-arm study implements a CHW-delivered diabetes intervention in community clinics distant from the parent research team.
Aim 1: Evaluate participant clinical outcomes (primary: HbA1c; secondary: blood pressure, cholesterol, BMI, and ADA adherence measures).
Aim 2: Monitor program sustainability through 36 months at the clinic level.
Aim 3: Assess implementation outcomes, including CHW knowledge, participant satisfaction, and attrition.
Inclusion/Exclusion:
Inclusion: Hispanic, Spanish-speaking adults ≥18 with type 2 diabetes and recent HbA1c.
Exclusion: Conditions affecting HbA1c, severe cognitive/mental illness, pregnancy, type 1 diabetes.
Study Design & Procedures:
Design: Single-arm study; all consenting participants receive the intervention. Recruitment: Clinic database search (ICD-10 E11.x) and provider referrals; verbal consent obtained.
Intervention Phases:
Clinic readiness assessment CHW training via telehealth Tele-mentored CHW delivery of 12-month program (group classes, weekly mHealth coaching, participant-clinician feedback loop)
Sustainability assessment through month 36
CHWs: Hispanic, Spanish-fluent, trained and certified; supported by experienced CHW instructors.
Safety: CHWs identify urgent issues for clinicians; standard diabetes care guidelines followed; HIPAA compliance ensured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHW-led diabetes program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Pressure | Change in systolic and diastolic blood pressure measured using standard clinical procedures. Blood pressure readings will be obtained at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention values. | baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Lescano Ventura | Contact | 409-772-2222 | valescan@UTMB.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth M. Vaughan, DO, MPH | University of Texas | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35132555 | Background | 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. | |
| 37898484 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change in Cholesterol Levels |
Change in lipid profile including total cholesterol, LDL, HDL, and triglycerides. Laboratory values will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention levels. |
| baseline to 12 months |
| Change in Body Weight | Change in body weight measured in kilograms using a calibrated scale. Measurements will be collected at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention weight. | baseline to 12 months |
| Change in Body Mass Index (BMI) | Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²). BMI will be assessed at baseline and follow-up visits. Change will be calculated as the difference between baseline and post-intervention BMI. | baseline to 12 months |
| Adherence to American Diabetes Association (ADA) Standards of Care | Adherence to ADA Standards of Care will be assessed based on predefined clinical indicators (e.g., HbA1c monitoring, blood pressure control, lipid management, and recommended screenings). Adherence will be evaluated using medical record review and/or standardized assessment tools. | baseline to 12 months |
| 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. |
| 37803098 | 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. |
| 34385148 | 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. |
| 30839244 | 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. |
| 29517061 | 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. |
| 29047326 | 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. |
| 32700217 | 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. |
| D004700 | Endocrine System Diseases |