Multi-clinic Action Trial to Control Hyperglycemia and Hypertension
Condition: Diabetes Mellitus, Type 2
MeSH terms: Hypertension; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) is
      a randomized controlled trial comparing two educational approaches to improve glucose and
      blood pressure control in African American and Latino adults with type 2 diabetes. The study
      is being designed and implemented using a Community Based Participatory Research approach to
      optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts
      a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American
      Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based
      Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general
      self-management education. The study seeks to determine if Community Health Workers working
      as part of the primary care clinical team can reduce health disparities and improve outcomes
      among patients with type 2 diabetes.
    

Detailed description: 
      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.
    

Intervention name(s): Home Based Enhanced Education; Clinic Based Enhanced Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Home Based Enhanced Education arm consists of a diabetes self-management curriculum delivered by Community Health Workers in the participant's home. Participants receive 24 visits: 12 biweekly visits in the first 6 months, followed by 12 monthly visits in months 6 through 18 of the study. The self-management program is derived from two pragmatic evidence-based frameworks for behavioral change.; The Clinic Based Enhanced Education arm consists of two two-hour-long sessions of group diabetes self-management education, delivered by a Certified Diabetes Educator. Participants in this arm will also receive 24 newsletters with diabetes self-management education.
Other intervention name(s): Community Health Worker intervention (CHW); Diabetes Educator intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: CHWs; Health Education; Disease Self Management