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.

MATCH2 Trained CHW Interventionists will work closely with patients to deliver a
participant-centered intervention derived from two pragmatic evidence-based frameworks for
behavioral change [Motivational Interviewing (MI) and Kate Lorig's Chronic Disease
Self-Management approach]. 24 total in-person visits will be conducted; six primary topics
will be covered multiple times over an 18-month period. No more than two topics will be
addressed at any visit. The sequence in which topics are delivered is determined by
participant need, preference, and interest. The six primary topics are:

1. Check glucose daily and know the goal.

2. Check blood pressure daily and know the goal.

3. Understand medications and take medications as prescribed.

4. Engage in 30 minutes of physical activity every day.

5. Enjoy a healthy natural diet with vegetables, fruit, and fiber.

6. Communicate any concerns to the health care team.

At each visit, CHWs will help participants develop a self-management Action Plan around one
of the six topics, and support problem solving behaviors to address barriers to completing
the Action Plan. Behavioral self-management skills will be taught by the CHW and practiced
with the participant at each visit. CHWs will monitor the clinic attendance of participants
and will advise and assist participants with making appointments with their primary care
providers at least once every 4 months. CHWs will also play an active role in communicating
the progress of their participants to the primary care providers using the clinic Electronic
Medical Record.

ENHANCED CLINIC-BASED EDUCATION CONDITION: Participants will receive group diabetes
self-management education, consistent with current Medicare guidelines for diabetes
education. A Certified Diabetes Educator will deliver the two class sessions (each two
hours) covering basic topics: diabetes (including self-management) and nutrition.
Participants will also receive 24 bilingual educational newsletters: twelve during the first
six months and then once a month between 6 and 18 months. The newsletters, called "Diabetes
Action", cover the same six self-management topics listed previously.

Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus with A1c greater than or equal to 7.0

- At least 18 years of age and capable of giving informed consent in either English or
Spanish

- Primary care received through a participating clinic

- Participants must identify themselves as either Black / African American race or
Hispanic / Latino ethnicity

Exclusion Criteria:

- Have end-stage renal disease, stroke, or other major end-organ complication of
diabetes

- Require chronic prednisone or other systemic corticosteroid use

- Are receiving treatment for a major psychiatric disorder (i.e. schizophrenia)

- Live in a household with someone who is already a randomized study participant