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)

Hamdard University

Status: Not yet enrolling

Conditions: Diabete Mellitus

Treatments: Behavioral: Pharmacist-led Cognitive Behavioral therapy; Other: Basic Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06807827

MU0624-IF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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385 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Basic Education

Cognitive Behavioral Interventional Group

Experimental group

Description:

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.

Treatment:

Behavioral: Pharmacist-led Cognitive Behavioral therapy