NCT06807333

Brief Summary

This interventional study is to evaluate the impact of pharmacist-led education on diabetic patients' knowledge, self-management, and overall health outcomes. Participants in this study will attend pharmacist-led educational sessions designed to improve their understanding of diabetes and self-care practices. Researchers will assess changes in patients' knowledge, self-management behaviors, and clinical health markers before and after the intervention. The study will compare pre- and post-intervention results to determine the effectiveness of pharmacist-led education in transforming diabetes care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
385

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Keywords

PharmacistPatient KnowledgeSelf-ManagementHealth OutcomeHbA1c

Outcome Measures

Primary Outcomes (3)

  • Diabetes Knowledge Score(DKQ-24)

    Patient's diabetes knowledge will be assessed using the Diabetes Knowledge Questionnaire (DKQ). The DKQ is a tool used to evaluate a patient's understanding of diabetes, including aspects such as blood sugar control, diet, exercise, and medication management. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score indicates a better level of knowledge regarding diabetes management.

    3 months

  • Diabetes Management Self-Efficacy Score (DMSQ-16)

    Patient's diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DMSQ). The DMSQ is a tool used to evaluate a patient's ability to manage their diabetes through self-care practices, including diet, physical activity, blood sugar monitoring, and medication adherence. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score reflects better self-management behaviors in managing diabetes.

    3 months

  • HbA1C Levels (%)

    Patient's health outcomes will be assessed using HbA1c levels. HbA1c (glycated hemoglobin) is a blood test used to measure a patient's average blood sugar level over the past 3 months. It is a key indicator of diabetes management and glycemic control. The HbA1c level is reported as a percentage, with lower percentages indicating better control of blood sugar. A target HbA1c level of less than 7% is typically recommended for most diabetic patients. The score can range from high percentages (indicating poor control) to lower percentages (indicating better glycemic control).

    3 months

Study Arms (1)

Interventional Group

EXPERIMENTAL

Lifestyle Modifications: Education on healthy meal choices and physical activity to support diabetes management. Disease Education: In-depth information on diabetes, blood sugar control, and the prevention of complications. Self-Management Tools: Provision of blood glucose monitoring charts and practical strategies for daily diabetes care. Counseling: Personalized counseling to address emotional aspects, stress management, and confidence in managing diabetes.

Behavioral: Pharmacist led Education

Interventions

Pharmacist-led education for diabetic patients focuses on enhancing their understanding of the disease, improving self-management skills, and promoting better health outcomes. The education covers key aspects of diabetes, such as the importance of blood sugar control, the role of diet and exercise, and how to monitor blood glucose levels. Patients are also taught effective self-management strategies, including how to make healthy food choices, incorporate physical activity into daily routines, and manage potential complications. By providing tailored education, pharmacists aim to empower patients to take an active role in their care, which can lead to improved disease management, better glycemic control, and reduced risk of complications.

Interventional Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • We will include all confirmed diabetic patients who visit the SIH endocrinology OPD Clinic during the study duration.
  • Both male and female patients visiting the Endocrinology Unit of the hospital will be eligible.
  • Patients with HbA1c levels greater than 8% will be included.
  • Both follow-up and newly diagnosed patients will be considered.
  • Patients who sign the informed consent form will be enrolled in the study.

You may not qualify if:

  • We will exclude patients with gestational diabetes mellitus (GDM).
  • Patients with central obesity will not be included in the study.
  • Type 1 diabetes mellitus (DM) patients under the age of 20 will be excluded.
  • Patients with inadequate medical history will be excluded from participation.
  • Patients with HbA1c levels less than 8% will not be included.
  • Patients who do not provide informed consent or express a lack of interest in the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa International Hospital

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Iqra Farooq, Mphil

    Shifa International Hospital

    STUDY DIRECTOR
  • Sara Ghulam Yahya, Ms.

    Shifa International Hospital

    PRINCIPAL INVESTIGATOR
  • Faiza Abbas, Pharm-D

    Shifa International Hospital

    STUDY CHAIR
  • Matti Ullah, PhD

    Hamdard University Islamabad Campus

    STUDY CHAIR
  • Salwa Ahsan

    Shifa International Hospital

    STUDY CHAIR
  • Osama Ishtiaq, Endocrinologist

    Shifa International Hospital

    STUDY CHAIR

Central Study Contacts

Iqra Farooq, Mphil

CONTACT

Matti Ullah, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Pharmacist

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

February 1, 2025

Primary Completion

May 30, 2025

Study Completion

July 31, 2025

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations