Design and rationale of a mixed methods randomized control trial: ADdressing Health literacy, bEliefs, adheRence and self-Efficacy (ADHERE) program to improve diabetes outcomes.

Background: Improving medication adherence is one of the most effective approaches to improving the health outcomes of patients with diabetes. To date, enhancing diabetes medication adherence has occurred by improving diabetes-related knowledge. Unfortunately, behavior change often does not follow knowledge change. Enhancing communication between patients and healthcare professionals through addressing health literacy-related psychosocial attributes is critical.

Objective: Examine whether a patient-centered intervention augmenting usual care with a health literacy-psychosocial support intervention will improve medication adherence for patients with diabetes, compared to usual care.

Methods: This study is a randomized controlled trial with an intervention mixed methods design. Fifty participants being enrolled are English-speaking, 18-80 years old with diagnosed diabetes, take at least one diabetes medication, have low diabetes medication adherence (proportion of days covered less than 80% or based on clinical notes), and have poor diabetes control (hemoglobin A1c of ≥8%). Participants will be allocated to either a control group receiving usual care (n = 25) or an intervention group (n = 25) receiving usual care and a 6-session intervention focusing on the modifiable psychosocial factors that may influence medication adherence. A questionnaire will be administered at baseline and at the end of the intervention to all participants to assess the effectiveness of the intervention. Fifteen participants from the intervention group will be interviewed to explore participants' experiences and perceptions of the intervention processes and outcomes.

Conclusions: The trial will examine if a patient-centered intervention that addresses patients' health literacy and focuses on modifiable psychosocial factors will improve medication adherence among patients with diabetes.