Impact of PharmaTE Trial on Glycemic Control, Diabetes Knowledge, Medication Adherence and Quality of Life in Type 2 Diabetes Patients: A Mixed-Method Study Protocol

The primary outcome is improved glycemic control compared to the baseline. The glycemic level will be assessed evaluating the HbA1c level at baseline and after intervention completion in both the interventional and control group Glycemic levels are considered normal when HbA1c level is within predefined ranges as suggested by the America Diabetes Association (ADA), which recommends that adults with diabetes maintain an HbA1c of less than 6.5 % (Eet al., 2024, 2025).

Patient knowledge about diabetes will be assessed using the Michigan Diabetes Knowledge Test (MDKT), which is validated tool that has been utilized in several settings to evaluate diabetic patients' knowledge. The Michigan survey instruments have been translated into several languages (Collins et al., 2011; Fitzgerald et al., 2016). The Michigan Knowledge Test (MDKT) is comprised of 14 multiple-choice questions. The knowledge test scores ranged from 0 to 14 with 14 representing the highest level of knowledge of diabetes and zero representing the lowest. We considered the knowledge score of <7 constituted poor knowledge, 7-11 moderate knowledge, and 12-14 good knowledge (Al-Aal., 2016). The Arabic version of the MDKT will be utilized, and permission for its use has been obtained from the to developer (Alhaiti et al., 2016).

Medication Adherence will be assessed to evaluate the patient's compliance with their treatment regimen using the Arabic version of Morisky Medication Adherence Scale (MMAS-8), The MMAS-8 is a validated assessment tool developed by Morisky et al (Morisky et al., 1986). MMAS-8 has good validity and reliability, has also been proven to be a useful screening technique for chronic disease medications, and has been validated on other Arabic patients suffering from chronic diseases (W.-Y. Lee et al., 2013; Sweileh et al., 2014).

The Diabetes Quality of Life (DQoL) questionnaire will assess diabetes quality of life (Al-Qerem et al., 2021). The questionnaire consists of 29 items divided into three factors: Satisfaction (14 items), Impact (11 items), and Worries (4 items). The satisfaction and impact questions include a 5-point Likert scale [very satisfied (1 point), quite satisfied, satisfied, little satisfied, and very dissatisfied (5 points)].

The DQOL questionnaire has been previously field-tested and validated for its administration in type 2 diabetic patients and shown to be internally consistent, reproducible, and responsive. It is commonly used and translated into several languages, including Arabic. The Arabic version of the DQOL questionnaire has previously been validated.

After completing the quantitative assessments, a semi-structured interview will be conducted with a subset of patients from the intervention group, three months after the intervention, via either a virtual meeting or a phone call, based on their preference. The interviews will focus on participants' feedback, challenges faced, and perceptions of the intervention's feasibility and acceptability. Semi-structured interviews will be conducted using an interview guide. With participants' consent, interviews will be audio-recorded, and then will be transcribed verbatum.

A purposive sampling technique will be used for recruiting the patients, the sample size is guided by data saturation for qualitative research, whereby no new themes appear from the data (Glaser & Strauss, 2017) It is anticipated that 15 to 25 interviews will be required to achieve data saturation (Glaser & Strauss, 2017).