Impact of PharmaTE trial on glycemic control, diabetes knowledge, medication adherence, and quality of life in type 2 diabetes patients: a mixed-methods study protocol

Background: Diabetes mellitus (DM) is a significant public health issue that requires lifelong management. Effective management requires a comprehensive approach integrating technology and clinical pharmacists into the healthcare team to improve glycemic control, patient knowledge, medication adherence, and quality of life. This study aims to evaluate the impact of a clinical pharmacist-led tele-educational intervention (PharmaTE trial) on glycemic control and patients' outcomes among patients with type 2 diabetes at a secondary care hospital in Ras Al Khaimah, United Arab Emirates (UAE). Methods: A mixed-methods embedded design will be employed, consisting of a randomised controlled trial (RCT) as the quantitative phase and a prospective descriptive qualitative study, a total of 154 adult patients diagnosed with uncontrolled type 2 diabetes, will be recruited and randomly assigned to either the (PharmaTE trial) intervention group (IG), which will receive five tele-education sessions led by a clinical pharmacist, or a control group (CG) receiving standard care. The primary outcome will be improved glycemic control, specifically achieving a target HbA1c level < 6.5% for individuals aged 18-65. Secondary outcomes will include improved diabetes knowledge, medication adherence, and quality of life, assessed using a validated Arabic version of the questionnaires: the Michigan Diabetes Knowledge Tool (MDKT), Morisky Medication Adherence Scale (MMAS), and Diabetes Quality of Life (DQOL). Moreover, the glycemic control will be evaluated by measuring HbA1c levels. Discussion: ClinicalTrials.gov identifier: NCT07043816.