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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 主要终点
- Glycemic Control
研究概览
简要总结
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:
- Does the PharmaTE trial improve blood sugar control (HbA1c levels)?
- Does it help patients better understand their condition?
- Does it increase how well patients follow their medication schedule?
- Does it improve the quality of life for patients with type 2 diabetes?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Due to the nature of the intervention study, the clinical pharmacist conducting the PharmaTE trial will be aware of whether the patient will be assigned to the PharmaTE trial interventional group (IG) or control (non-blinded). However, the investigators who will collect the data from each patient before and after the intervention will be blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Glycemic Control
时间窗: 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.
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).
Glycemic Control
时间窗: 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.
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).
次要结局
- 3. Medication Adherence(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
- Diabetes Knowledge(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
- Diabetic Quality of Life(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
- Diabetes Knowledge(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
- 3. Medication Adherence(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
- Diabetic Quality of Life(Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).)
研究者
Rabia Hussain
DR. Rabia Hussain, Principal Investigator
Universiti Sains Malaysia