The goal of this clinical trial is to find out whether a pharmacist-led tele-educational program (PharmaTE trial) can help people with type 2 diabetes manage their condition better.
The main questions this study aims to answer are:
1. Does the PharmaTE trial improve blood sugar control (HbA1c levels)? 2. Does it help patients better understand their condition? 3. Does it increase how well patients follow their medication schedule? 4. Does it improve the quality of life for patients with type 2 diabetes? 5. Is this type of tele-education program feasible and acceptable for patients?
Participants will:
Be randomly placed into one of two groups:
Intervention group: Receive five virtual education sessions with a clinical pharmacist over the phone or via Zoom (each lasting 20-30 minutes), in addition to their usual diabetes care.
Control group: Continue receiving standard diabetes care from their healthcare team without the additional pharmacist-led sessions.
Complete assessments at the beginning and end of the study. These include:
A blood test for HbA1c
, Questionnaires on diabetes knowledge, medication adherence, and quality of life
Some participants in the intervention group will be invited for interviews after the sessions to share their experiences and opinions about the program.
Who can join? Adults aged 18-65 with uncontrolled type 2 diabetes (HbA1c \> 7%), receiving care at Ibrahim Bin Hamad Obaidullah Hospital in Ras Al-Khaimah, who speak Arabic and can provide consent.
Patients diagnosed with uncontrolled type 2 diabetes (defined as glycated haemoglobin [HbA1c] >7%) within the previous 12 months
Adults (18 to 65 years) of either gender
Prescribed at least one antidiabetic medication
Have access to either a telephone or a mobile phone
Under 18 years old
Pregnant ladies
Patients admitted to the emergency department
Patients with severe hepatic or renal dysfunction
Parallel
PharmaTE Trial
BehavioralIn addition to standard care, patients in the PharmaTE trial interventional group will receive tele-education led by a clinical pharmacist who has completed a training course and is certified as a diabetes educator. The tele-education program is comprised of five individualized educational sessions, each lasting approximately 20-30minutes and held at two-month intervals. These sessions are conducted via Zoom or telephone based on patient preference. Before the beginning of each session, participants will receive a reminder message along with the Zoom meeting invitation link about the session, covering various educational topics related to diabetes management. Additionally, after each session, patients will receive a brochure summarizing what has been discussed.
Glycemic Control
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).
Diabetes Knowledge
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).
3. Medication Adherence
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).
Diabetic Quality of Life
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.
Feasibility and Acceptability
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).
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Rabia Hussain
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Universiti Sains Malaysia
Collaborator
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