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

Обзор

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.

Подробное описание

This study evaluates the impact of a clinical pharmacist-led tele-educational intervention (PharmaTE trial) on glycemic control, diabetes knowledge, medication adherence, and quality of life among adult patients with type 2 diabetes mellitus (T2DM) at a secondary care hospital in Ras Al Khaimah, United Arab Emirates.

The rationale for the study stems from the increasing prevalence of T2DM in the region, with many patients experiencing poor glycemic control and limited access to diabetes education. Previous evidence suggests that pharmacist-led interventions can improve treatment adherence and health outcomes. However, such approaches, particularly via tele-education, remain underexplored in the UAE healthcare setting.

This is a mixed-methods study with an embedded design consisting of a prospective, randomized controlled trial (RCT) and a qualitative component. A total of 154 eligible adult patients with uncontrolled T2DM (HbA1c \> 7%) will be randomly assigned to either an intervention group or a control group. The intervention group will receive five tele-education sessions delivered by a clinical pharmacist, focusing on key aspects of diabetes self-management. The control group will continue to receive standard care without pharmacist-led education.

Baseline and post-intervention assessments (after 3 months) will include HbA1c levels, patient knowledge (Michigan Diabetes Knowledge Tool), medication adherence (MMAS-8), and quality of life (DQoL). A subset of intervention participants will also be interviewed to explore the feasibility and acceptability of the program.

The findings are expected to support the integration of pharmacists into diabetes care models and inform future digital health strategies.

Вмешательства

• Поведенческое PharmaTE Trial
  In 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, particip

Первичные конечные точки

• Glycemic Control [Срок оценки: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention). Patients whose has been measured within the last two weeks will not be required to undergo repeat testing.]

Вторичные конечные точки (3)

• Diabetes Knowledge [Срок оценки: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).]
• 3. Medication Adherence [Срок оценки: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).]
• Diabetic Quality of Life [Срок оценки: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).]

Критерии участия

Критерии включения

• 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
• Treated in an outpatient facility in IBOH, RAK
• Arabic-speaking patients
• Patients who understand study information and are given written informed consent.

Критерии исключения

• Under 18 years old
• Pregnant ladies
• Patients admitted to the emergency department
• Patients with severe hepatic or renal dysfunction
• Diagnosed with type 1 DM or diagnosed with gestational diabetes
• Having vision or hearing impairments and psychological problems
• Immunocompromised patients, e.g., organ transplants, AIDS, cancer patients, and patients on immunosuppressant therapy
• Patients with no or limited access to either a telephone or mobile phone, as well as those without reliable internet access

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Ahmad NA, Hussain R. 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. J Pharm Policy Pract. 2026 Apr 14;19(1):2645906. doi: 10.1080/20523211.2026.2645906. eCollection 2026. PMID 42027207

Идентификаторы

NCT: NCT07043816 · USM-DSAP-2025-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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