mHealth for Diabetes Adherence Support
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the benefit and cost of including health
      coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and
      videoconferencing in diabetes management support services for African-Americans and Latinos
      with uncontrolled Type 2 Diabetes.
    

Detailed description: 
      Many African-Americans and Latinos with diabetes do not achieve recommended diabetes goals
      placing them at high risk for complications. Team-based models of care can help in reaching
      goals of therapy. Additionally, mobile health (mHealth) technologies can further improve
      outcomes among those more difficult to reach. This study will evaluate the impact of a
      team-based, mHealth intervention designed to improve medication adherence, healthy eating,
      and physical activity behaviors. The investigators will compare this mHealth approach with
      usual care.

      Clinical pharmacists and health coaches (HC) will deliver our proposed team-based
      intervention. mHealth delivery includes mobile phone text messaging, secure
      videoconferencing, and HC home visits. Pharmacists will focus on medication reconciliation
      and adherence. Health coaches will help identify psychosocial and environmental challenges to
      adherence in a culturally-sensitive manner. Together, they can assist in goal-setting,
      problem-solving, negotiation of competing priorities, and provide social support leveraging
      mHealth technologies.

      Preliminary data from previous research by the research team supports the role of health
      coaches partnering with clinic- based pharmacists in improving diabetes outcomes in
      minorities. In the proposed mHealth intervention, patient- pharmacist videoconferencing will
      eliminate the need for in-person visits with a pharmacist, which is impractical for many
      low-income patients. In addition, pilot work suggests that text messaging is a preferable
      means of communication and may facilitate more frequent contact with patients.

      This is a randomized, controlled trial to evaluate the effectiveness of an mHealth diabetes
      adherence support intervention delivered by clinical pharmacists and health coaches. The
      research team will randomize 220 patients through UI Health to either: (1) mHealth diabetes
      adherence support through clinical pharmacists and health coaches; or (2) usual care. After
      one year, patients completing the mHealth intervention will be monitored for an additional
      year while the usual care group receives the mHealth approach. Outcomes include medication
      adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. The specific aims
      include: (1) evaluate the effectiveness of an mHealth diabetes adherence support intervention
      delivered by clinical pharmacists and health coaches to African-American and Latino adults
      with uncontrolled type 2 diabetes; (2) evaluate the maintenance of improved diabetes
      behaviors as well as clinical outcomes one year after completing the intervention; (3)
      evaluate the cost and cost-effectiveness of mHealth diabetes adherence support compared to
      usual care; and (4) evaluate the reach, adoption, and implementation of mHealth diabetes
      adherence support based on the RE-AIM framework.
    

Intervention name(s): mHealth for Diabetes Adherence Support
Intervention type(s): Behavioral
Intervention description(s): Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.
Other intervention name(s): mDAS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 2-arm, parallel, randomized controlled trial. Patients are randomized 1:1 to (1) mHealth diabetes adherence support intervention for one year and monitored with usual care for the second year, or (2) wait-list usual care for one year, then intervention during the second year.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 2; Medication Adherence; Telemedicine; Community Health Workers; Pharmacists; Mobile Health