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Type 2 Diabetes (T2DM)PharmaTENCT07043816

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

A study testing PharmaTE Trial in people with Type 2 Diabetes (T2DM) and Glycemic Control, run by Rabia Hussain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
PharmaTE Trial
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Rabia Hussain, PhD, Lecturer contact

+60-46534085

rabia.hussain@usm.my

About this study

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:

Read more
  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.

Read the detailed description

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.

Being tested
PharmaTE Trial
Keywords
PharmaTE
Medical subject headings
Diabetes Mellitus, Type 2, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PharmaTE TrialBehavioural

    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, 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.

Study groups in NCT07043816
Study groupRoleWhat they receive
Control GroupNo interventionPatients randomized to the control group will receive standard care provided in a diabetes excellence center, including nurse assessment, physician assessment, and care provision by a multidisciplinary team. They will also visit the hospital pharmacy to fill their prescriptions without further clinical pharmacist intervention. However, there will be no restriction on contacting the clinical pharmacist for advice.
Interventional Group (PharmaTE group)ExperimentalIn 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.
Receives: Behavioral: PharmaTE Trial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

Secondary outcomes (3)

  1. 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).

    Measured: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).

  2. 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).

    Measured: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).

  3. 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.

    Measured: Both groups will assessed at baseline and after the end of the intervention (3 months after completing the intervention).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2025
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07043816
Sponsor's protocol ID
USM-DSAP-2025-002
Acronym
PharmaTE
Status last verified
Apr 2026
First submitted
20 Jun 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 42027207

Questions about this trial

What is this clinical trial studying?

A study testing PharmaTE Trial in people with Type 2 Diabetes (T2DM) and Glycemic Control, run by Rabia Hussain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rabia Hussain, PhD, Lecturer (+60-46534085, rabia.hussain@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Control (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07043816, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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