Transforming Diabetes Care: Pharmacist-Led Education and Its Impact on Patient Knowledge, Self-Management, and Health Outcomes (TRIPLE-CARE)

January 29, 2025 updated by: SARA YAHYA, Shifa International Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to investigate whether pharmacist-led education can enhance the knowledge, self-management behaviors, and health outcomes of diabetic patients. Effective diabetes management requires a comprehensive understanding of the disease, adherence to lifestyle modifications, and consistent monitoring of health indicators. Poor knowledge and suboptimal self-care can lead to inadequate glycemic control, complications, and reduced quality of life. This study will evaluate the impact of pharmacist-led educational interventions on patients' motivation, diabetes-related knowledge, and self-care behaviors, as well as their effects on clinical outcomes, including improved HbA1c levels, reduced hypo- and hyperglycemic episodes, and enhanced patient satisfaction. By addressing these critical aspects, the study aims to highlight the transformative role of pharmacist-led education in advancing diabetes care and fostering sustainable, patient-centered healthcare practices.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Shifa International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetes Knowledge Score(DKQ-24)
Time Frame: 3 months
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)
Time Frame: 3 months
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 (%)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shifa International Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Iqra Farooq, Mphil, Shifa International Hospital
  • Principal Investigator: Sara Ghulam Yahya, Ms., Shifa International Hospital
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 318-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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