NCT Number: NCT07538505
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline to 12 months
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
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
The University of Texas Medical Branch, Galveston
Other
Implementing a Diabetes Intervention in Rural and Low-Income Clinics: A Feasibility Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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