Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life (COGNIPHARM-II)

January 29, 2025 updated by: Matti Ullah, Hamdard University

Pharmacist-Led Educational Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life

This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of medication adherence and quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if educational interventions along with Cognitive Behavioral Therapy (CBT) can have a favorable effect on various aspects of diabetes management coping techniques, Medication beliefs, reduction in hypo and hyperglycemic frequency, HbA1c and medication related problems (MRPs) medication adherence and overall quality of life of diabetic patients.

Study Type

Interventional

Enrollment (Estimated)

385

Phase

  • 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 Backup

  • Name: Iqra Farooq, M.Phil Pharmacy Practice

Study Locations

  • Pakistan
    • ICT
      • Islamabad, ICT, Pakistan, 44000
        • Shifa International Hospital
        • Contact:
          • Iqra Farooq, Mphil Pharmacy Practice
          • Phone Number: 03335644661
          • Email: iqra0989@gmail.com
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.

Patients having HbA1c >8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.

Exclusion Criteria:

GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c <8% Patient who are not interested in the study are 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Routine healthcare practices and protocols for diabetes management. Regular advice on medication, diet, and lifestyle modifications in accordance with established guidelines, Follows conventional approaches. Lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and medicine. Pill planner will be provided to keep them adherent to their medication. General Medication counselling.
Other: Basic Education
Basic Education about lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and medicine. Pill planner will be provided to keep them adherent to their medication. General Medication counselling.
Experimental: Cognitive Behavioral Interventional Group

Specific Patient-centered strategies beyond routine care designed to address individualized needs. Customized interventions, including pharmacist-led educational sessions, personalized counseling, or advanced lifestyle modifications. Aims to enhance patient outcomes by providing tailored and innovative solutions for better diabetes management.

Change in lifestyle / link with any daily activity (Yoga and Meditation Specifically guide about food portions and how to balance each food group in daily routine along with recommended daily physical activity type and duration. Pill planner will also be provided to this group.

Medication counselling, Insulin technique, Dose Adjustment, Titration, Insulin Correction.

Cognitive Behavioral Therapy will be provided.
Behavioral: Pharmacist-led Cognitive Behavioral therapy
Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence score
Time Frame: 3 months

Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.

This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence <6 is poor adherence, and >8 is high adherence.
3 months
Quality of life Score
Time Frame: 3 months
Patient's quality of life will be assessed using Revised Version of DQOL (RV-DQOL13 ; Audit of diabetes dependent quality of life) will be used to access the quality of life of the patient. Its scoring ranges from 1- 100
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Drug-Drug Interactions
Time Frame: 3 months
Drug interactions among oral anti glycemic and other drugs will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervention in both control and Cognitive Behavioral Intervention groups.
3 months
HbA1c %
Time Frame: 3 months
HbA1c levels (%) will be assessed before the intervention is provided and after 3 months.
3 months

Collaborators and Investigators

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

Sponsor

Hamdard University

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)

February 20, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU0624-IF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing will be dependent on the consent provided by the patient.

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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