Improving Diabetes Medication Adherence for African Americans in Madison and Milwaukee Through Peer Support
Condition: Type2 Diabetes; Medication Adherence; Medication Nonadherence; Peer Support
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The burden of diabetes is higher among African Americans (AAs) in Wisconsin as
      hospitalization rates for diabetes complications such as stroke and amputations are four
      times higher than whites and has worsened by 334% since 2011. The most important
      self-management behavior for improving diabetes outcomes is medication adherence, i.e.,
      taking medicines as recommended by providers. Poor adherence to diabetes medications is
      common among AAs and contributes to disproportionally worse outcomes. While the reasons for
      nonadherence are multifactorial, health beliefs, lack of self-efficacy, social support, and
      limited health literacy, are critical factors for AAs. Due to discrimination experiences and
      provider distrust, AAs may have health beliefs that do not align with biomedicine. Existing
      adherence interventions designed for general populations may be ineffective for AAs because
      they do not adequately address these fundamental factors.

      The intervention is peer-led, such that AAs who have diabetes and are adherent to their
      medicines (Peer Ambassadors- (PAs)) are paired with AAs who have diabetes and are nonadherent
      (Peer Buddies- PBs)).Throughout the 8-week program, PAs actively support and teach PBs about
      self-advocacy in patient-provider relationships, as well as sharing their experiences
      managing diabetes, providing social support, enhancing health literacy, patient activation
      (engagement and empowerment) and self-efficacy. PAs help deliver the intervention via initial
      face-to-face and phone/app follow-ups with PBs, in addition to structured group education
      delivered to PBs by a physician, pharmacist, and diabetes educator separately. The
      investigator's aim is to use a community-engaged design to pilot the intervention, assessing
      the feasibility of gathering pre/post outcomes including culturally-informed diabetes-health
      beliefs, self-efficacy, patient activation, medication adherence (using surveys), and A1c,
      and further refine the intervention via feedback from an advisory board comprised of the PAs.

      The investigators hypothesize that the intervention will be feasible for AAs with diabetes.
      This study uses a collaborative approach involving patient stakeholders throughout the
      research process by directly engaging AAs with diabetes to utilize their experience,
      knowledge and advice. This project advances the development of culturally-appropriate
      medication adherence interventions for AAs with diabetes.
    

Detailed description: 
      In the United States, diabetes affects 3.7 million African Americans (AAs) who are more
      likely to be diagnosed compared to non-Hispanic whites and are at a greater risk for
      diabetes-related death and disability. Diabetes is the seventh leading cause of death in
      Wisconsin, incurring an estimated $3.9 billion annually in health care and lost productivity
      costs. Each year, more than 1,300 people in Wisconsin die from diabetes and many more suffer
      diabetes-related complications such as heart disease and amputations. This burden is higher
      among African Americans (AAs) whose hospitalization rates for diabetes-related complications
      are four times higher than whites. The most important self-management behavior for improving
      diabetes outcomes is medication adherence, i.e., taking medications according to provider
      recommendations. Poor medication adherence places a significant economic burden on US
      healthcare systems, resulting in $290 billion in costs. A nonadherent patient requires three
      extra medical visits per year, leading to $2000 increased treatment costs annually. In
      diabetes, the estimated US cost savings due to improving poor adherence is $1.16 billion.
      Nonadherence is thus a critical societal problem with negative economic consequences and
      detrimental effects on health and well-being.

      Poor adherence to diabetes medicines is common among AAs and contributes to disproportionally
      worse diabetes outcomes for AAs. AAs have a 25% lower adherence to diabetes medications than
      non-Hispanic whites. While the reasons for nonadherence are multifactorial, health beliefs,
      lack of social support, and limited health literacy, are critical factors for AAs. Due to
      limited access to high quality healthcare, discrimination experiences, and distrust in
      providers, AAs may have health beliefs that do not align with biomedicine. Existing adherence
      interventions designed for general populations may be ineffective for AAs because they do not
      adequately address these fundamental psychosocial factors. The proposed work builds on the
      investigator's studies of AAs' diabetes experiences and medication adherence. The
      investigator's previous research showed that AAs felt a loss of autonomy because of diabetes
      and believed that diabetes was caused by exposure to certain medications. Navigating the
      healthcare system seemed difficult. Some AAs did not take their medicines because they did
      not know how to ask their provider questions. AAs wanted peers to support/teach self-advocacy
      and positive empowerment in patient-provider relationships. Hence, the investigators worked
      with community/patient stakeholders to develop a prototype 8-week peer-led culturally
      appropriate intervention to address identified psychosocial/ sociocultural issues and enhance
      diabetes medication adherence for AAs, called Peers Supporting Health Literacy,
      Self-Efficacy, Advocacy and Adherence (Peers LEAD).

      Typically, peer support occurs through group, nurse and community health worker visits;
      however, these require expensive professional staff. Peers LEAD offers an innovative,
      culturally appropriate and more informal, low-cost means of providing peer support with
      similar benefits. The long-term goal is to decrease diabetes-related morbidity among AAs
      through culturally appropriate interventions to increase medication adherence. The study
      objective is to pilot Peers LEAD using a community-based participatory design to examine for
      feasibility, outcomes including culturally-informed diabetes-health beliefs, diabetes and
      medication self-efficacy, patient activation (a measure of engagement/empowerment),
      medication adherence, and blood glucose, and refine Peers LEAD via participant feedback. The
      central hypothesis is that Peers LEAD will be feasible and effective for AAs with diabetes,
      leading to improved outcomes in self-efficacy, activation, adherence, and blood glucose. The
      study aims are:

      Aim 1: To pilot PEERS LEAD to test the feasibility and acceptability of the intervention
      intended to shift negative diabetes-health beliefs to positive, enhance diabetes
      self-efficacy, and improve adherence, and blood glucose levels. In conjunction with an
      interdisciplinary team of a physician, pharmacist and diabetes educator who will provide
      structured education, Peer Ambassador Board (PAB) members will help deliver Peers LEAD, via
      initial face-to-face and phone/messaging app follow-ups, serving as peer ambassadors (PAs).
      Peer buddies (PBs) (AAs 30-65 years old with type 2 diabetes and poor medication adherence)
      will participate in the program, with a target of 10 20 PBs each in Madison and 10 PBs in
      Milwaukee. PBs will complete surveys and glucose tests assessing changes in outcomes.
      Interviews and focus groups will be conducted with all PBs and PAs respectively to get
      feedback on the intervention. The investigators hypothesize that PA/PB feedback will lead to
      a feasible intervention showing improvement in adherence and glucose levels for the PBs.

      Aim 2: To refine PEERS LEAD for AAs with diabetes using feedback from Peer Ambassador Boards
      and Peer Buddies. The investigators will: (1) establish two PABs, (2) train PAB members as
      PAs, (3) elicit feedback to refine Peers LEAD.

      This study uses a collaborative approach involving patient stakeholders throughout the
      research process by directly engaging AAs with diabetes to utilize their experience,
      knowledge and advice. This is the first study to enhance peer support for AAs with diabetes
      using phone/messaging app technology. This project advances the development of innovative
      interventions for AAs with diabetes and focuses on social and behavioral constructs
      identified from the investigator's prior work to influence medication adherence.

      Overall Study Design: This pilot research will be conducted in 2 phases using an intervention
      mixed methods design in which the investigators will test the 8-week Peers Supporting Health
      Literacy, Self-Efficacy, Advocacy and Adherence (Peers LEAD) intervention in Phase 1, and
      then examine specific intervention elements for refinement in Phase 2. The rationale for this
      design is that neither quantitative nor qualitative methods are sufficient in explaining the
      outcomes of the intervention. Mixing both methods gives a more complete analysis of Peers
      LEAD. Qualitative results collected during and after the intervention will allow the
      investigators to further explain the outcomes, examine participant's experiences and modify
      the methods in a follow-up and/or dissemination study.
    

Intervention name(s): Peers Supporting Health-Literacy, Self Efficacy, Advocacy and Adherence
Intervention type(s): Behavioral
Intervention description(s): An 8-week culturally appropriate educational behavioral intervention that consists of structured group diabetes education and follow-up peer support with PAs. There will be 3 separate group education sessions led by a physician, AA pharmacist and AA diabetes educator. All PAs will attend each group session to learn together with their PBs and build social interactions. Weeks 1 and 2 consist of 2-hour group education between the participants and diabetes educator, and participants and pharmacist, respectively. Pre-test intervention data including A1c will be collected in Week 1. In Weeks 3-7, PAs will deliver the intervention content to PBs over the phone as well as help them set a goal towards getting healthy. An existing video/text messaging app, called WhatsApp® will be offered as an option to use to further enhance PA-PB interaction.
Other intervention name(s): Peers LEAD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Peer Support; Type2 Diabetes; African American