MATCH2: The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension

MATCH2, a randomized controlled trial, will test if the optimized CHW-delivered intervention can reduce both Hemoglobin A1c levels and blood pressure at eighteen months in persons with uncontrolled diabetes, as compared to a CDE-delivered group educational program. Follow-up six months after the completion of the intervention will evaluate the sustainability of any gains. MATCH2 will use precise measures of diet (food frequency questionnaires) and physical activity (accelerometry) to identify intermediate behaviors and processes that mediate significant improvements in glycemic and blood pressure control.

Patients/participants will be recruited from three participating urban primary care safety net clinics to join MATCH2 if patients meet the inclusion and exclusion conditions (see criteria section below). Eligible patients interested in participation will have a baseline visit scheduled. Baseline assessments may be conducted either at the clinic, the participant's home, or the Rush Prevention Center, at the patient's preference. At the baseline visit, the research assistant will obtain informed consent for the study as approved by the Institutional Review Boards (IRB) of participating institutions. The baseline assessment will include the following measures: demographics, clinical data, glycemic control, blood pressure, total caloric and sodium intake, physical activity, medication adherence, clinic attendance, quality of life, patient activation, depression and social support.

A randomization scheme based on permuted randomized blocks of size 4 and 6 will be used, stratified by clinic. Randomization schedules will be developed by the study Biostatistician and the Data Management Team will assign participants to treatment or control groups accordingly.Of the investigative team, the Principal Investigator, identified Key Co-Investigators and all research assistants will be blinded to the patient's group assignment while remaining research team: the Community Health Workers (blinded to study hypothesis), selected Key Co-Investigators, Site Principal Investigators, and Data Management Team will be unblinded.

Participants will know the study condition to which participants have been assigned. As with the CHW interventionists, participants will be blinded to the study hypothesis. Consent and recruitment forms will all state that "The MATCH2 trial is comparing two clinic-based approaches to improve control of high blood sugar and high blood pressure in people with type 2 diabetes. Some evidence suggests that approaches such as health classes led by a diabetes educator, coaching by Community Health Workers, and printed diabetes education materials may help improve outcomes for people with uncontrolled diabetes.

ENHANCED HOME-BASED EDUCATION CONDITION: CHW Interventionists deliver diabetes self-management curriculum in the participant's home or other preferred setting.