Peers LEAD Plus Healthy Living With Diabetes (HLWD)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The specific goal of this project is to decrease diabetes-related morbidity among African
      Americans (AAs) in Milwaukee through the integration of Peers LEAD, a culturally-appropriate
      program to increase medication adherence into Healthy Living with Diabetes (HLWD), an
      existing diabetes self-management program.
    

Detailed description: 
      This project represents the next phase of prior work at the University of Wisconsin School of
      Pharmacy to create and implement community-based programs for AAs with diabetes that focus on
      improving medication use and glycemic control. The overall objective is to integrate Peers
      LEAD into HLWD using a community-engaged approach and an evaluation to document outcomes.
      This project will produce a culturally-tailored curriculum that can be used broadly across
      social service and community organizations, faith-based organizations, and
      federally-qualified health centers committed to improving AAs diabetes self-management. This
      project will be achieved through the following objectives:

        -  Objective 1: To gather and incorporate key stakeholders input in the current and future
           adoption of Peers LEAD+HLWD into community organizations, health system and/or
           practices. Objective 1 is not a clinical trial.

        -  Objective 2: To implement and measure the outcomes of Peers LEAD+HLWD to improve
           medication adherence and hemoglobin A1c. Objective 2 represents the clinical trial aim
           of this study to be registered in this record.

      HLWD is a successful community-based program that offers tools and resources to enhance
      understanding of what it means to have diabetes, including helping participants to build the
      confidence to manage diabetes and maintain an active and fulfilling life. HLWD is endorsed by
      the American Diabetes Association and the Centers for Disease Prevention and Control and
      proven to reduce emergency department visits by 53%, improve A1c levels, enhance regular
      treatment and diabetes education, create a community-clinical link in care, provide social
      benefits for participants, improve self-rated health and communication with physicians, and
      improve health status, health behavior, and self-efficacy. The investigators chose HLWD as
      the diabetes self-management education (DSME) program to adapt because it is an effective and
      widely-disseminated evidence-based DSME program. HLWD has enrolled over 5,000 participants in
      more than 400 workshops across 52 Wisconsin counties. However, between 2013 and 2016, only
      120 AAs (3.1%) participated compared to 1,656 non-Hispanic Whites. In 3 years, only 46% of
      AAs reported that they took their diabetes pills (HLWD's measure of medication adherence)
      after the workshop, compared to 55% of non-Hispanic Whites. Despite HLWD's positive outcomes
      and wide reach, there is limited inclusion of AAs. HLWD does not offer culturally-tailored
      content for AAs, and lacks one-on-one peer support from an AA who successfully manages
      diabetes, an important factor influential in improving diabetes outcomes among AAs. There is
      also insufficient attention to medication adherence. Adding Peers LEAD to HLWD will improve
      the reach, effectiveness, and impact of diabetes self-management programs among AAs.

      Peers LEAD is a culturally-tailored program designed to provide AAs with diabetes and
      medication beliefs information, behavioral skill-development, and one-on-one peer support to
      increase medication adherence. Group sessions include discussions of personal discrimination
      experiences that resulted in provider mistrust, making the most of clinic/pharmacy visits,
      necessity and concerns about medicines, and enhancing patient-provider communication.
      Ambassadors are paired with Buddies, and Ambassadors help deliver Peers LEAD content via
      face-to-face interaction with their Buddies during group sessions and phone follow-ups.
      Ambassadors address misperceptions of medicines and diabetes, share their experiences
      managing diabetes and medicines, and discuss building relationships with providers. As well,
      they are able to provide one-on-one social support.

      Peers LEAD+HLWD allows for sufficient attention to medication adherence in a DSME program.
      For example, HLWD includes only one 20-minute activity on medication use in a 2½ hour session
      during Week 5. This activity only covers purpose of medicines, medication effects, and
      remembering to take medicines, but does not address known specific barriers to AAs adherence.
      In this study, HLWD will be adapted for AAs by adding components of Peers LEAD to overcome
      key barriers to AAs medication adherence. Core components of Peers LEAD to be incorporated
      are two group sessions on beliefs about medicines and diabetes, discrimination/mistrust, and
      provider communication, as well as peer-based phone support from Ambassadors.

      The investigators hypothesize that, by implementing Peers LEAD+HLWD, there will be increased
      reach, engagement, and impact for AAs because psychosocial/sociocultural factors and barriers
      identified in their work to influence AAs medication adherence (i.e., culturally embedded
      health beliefs and provider mistrust) will be addressed.

      Objective 2 is a pre-post single group design to conduct Peers LEAD+HLWD in Milwaukee. There
      will be two groups of participants: (1) Ambassadors (who are not consented into the
      intervention, but help facilitate it) - AAs who have diabetes and are adherent with their
      medicines and (2) Buddies (consented into the intervention) - who are AAs who have diabetes
      but are nonadherent with their medicines.

      Training of Ambassadors: To prepare to implement Peers LEAD+HLWD, Ambassadors will attend a
      6-hour orientation and training meetings, co-facilitated by Wisconsin Network for Research
      Support (WINRS). This meeting will be an orientation and will prepare the Ambassadors to
      implement specific elements of Peers LEAD+HLWD, such as the phone calls. WINRS will consult
      with the research team on all meetings. For >8 years, WINRS staff have been deeply involved
      in stakeholder engagement, as well as trained, planned and facilitated >250 lay advisory
      board meetings.

      Ambassadors are involved in two group sessions focusing on beliefs about medicines and
      diabetes, discrimination/mistrust, and communication with providers, and peer-based phone
      support with buddies to occur weekly for the first 2 weeks, then for 5 weeks after the
      completion of the 8-week program. Building on the previously piloted version of Peers LEAD,
      Peers LEAD + HLWD has added phone-based peer support from Ambassadors comprised of bi-weekly
      calls to monitor progress toward goals (Month 4) and finally monthly calls to support goal
      adherence (Months 5-6), representing the Maintenance Phase.
    

Intervention name(s): Peers LEAD plus HLWD
Intervention type(s): Behavioral
Intervention description(s): Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Medication adherence