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

The University of Texas System (UT)

Status: Begins enrollment this month

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Community Health Worker-led diabetes program

Study type: Interventional

Funder types: Other

Identifiers

NCT07538505

25-0360

Details and patient eligibility

About

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

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

CHW-led diabetes program

Experimental group

Treatment:

Behavioral: Community Health Worker-led diabetes program