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

NCT ID: NCT06807827

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in. Moreover, following intervention, the outcomes will be assessed by the investigator who will be blinded about the participant group.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Basic Education

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Pharmacist-led Cognitive Behavioral therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamdard University

OTHER

Sponsor Role lead

Responsible Party

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Matti Ullah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shifa International Hospital

Islamabad, ICT, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Matti Ullah, Ph.D Clinical Research

Role: CONTACT

+92-331-5056501

Iqra Farooq, M.Phil Pharmacy Practice

Role: CONTACT

Facility Contacts

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Iqra Farooq, Mphil Pharmacy Practice

Role: primary

03335644661

Sara Ghulam Yahya, Ms Health Care Management

Role: backup

Other Identifiers

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MU0624-IF

Identifier Type: -

Identifier Source: org_study_id

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