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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: CHW-led diabetes programExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
baseline to 12 months

Secondary outcomes

1

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.

Time frame
baseline to 12 months
2

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.

Time frame
baseline to 12 months
3

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.

Time frame
baseline to 12 months
4

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.

Time frame
baseline to 12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: