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

NCT07043816 | Not Yet Recruiting

• 1 other identifier: USM-DSAP-2025-002
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does the PharmaTE trial improve blood sugar control (HbA1c levels)?
2. 2.Does it help patients better understand their condition?
3. 3.Does it increase how well patients follow their medication schedule?
4. 4.Does it improve the quality of life for patients with type 2 diabetes?
5. 5.Is this type of tele-education program feasible and acceptable for patients?

Conditions

Diabetes Knowledge; Medication Adherence; Quality of Life; Type 2 Diabetes (T2DM); Glycemic Control

Keywords

PharmaTE

Outcome Measures

Primary Outcomes (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).

  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)

• 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).

Other Outcomes (1)

• Feasibility and Acceptability

  Three months after completing the intervention

Study Arms (2)

Control Group

NO INTERVENTION

Patients 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)

EXPERIMENTAL

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.

Behavioral: PharmaTE Trial

Interventions

PharmaTE Trial BEHAVIORAL

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.

Interventional Group (PharmaTE group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabia Hussain: lead
• Universiti Sains Malaysia: collaborator

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Rabia Hussain, PhD, Lecturer

CONTACT

+60-46534085; rabia.hussain@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR. Rabia Hussain, Principal Investigator

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04