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Clinical Trials/NCT06034353
NCT06034353
Completed
Not Applicable

Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients

Hamdard University1 site in 1 country385 target enrollmentSeptember 22, 2023
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Hamdard University
Enrollment
385
Locations
1
Primary Endpoint
Medication adherence
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this interventional study is to assess the impact of pharmacist-led cognitive behavioral intervention in epileptic patients. The main questions are:

  1. If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence?
  2. How will the cognitive behavioral therapy impact the quality of life of the patients?

Participants of this study will be provided basic or advanced level counselling and educational material as part of their routine pharmacy visit.

Researchers will compare the two groups (Basic and advanced) to see which of the two groups are better in term of medication adherence and quality of life.

Detailed Description

The purpose of the study is to investigate whether incorporation of pharmacist-led cognitive behavioral therapy (CBT) to the treatment of epileptic patients can result in better adherence to anti epileptic drugs. In order to manage epilepsy effectively, medication adherence is essential. Missed doses or irregular drug use can increase the frequency of seizures and reduce the effectiveness of treatment. In order to improve medicine adherence rates, the study will examine if cognitive behavioral therapy (CBT) therapies can have a favorable effect on patients' motivation, coping techniques, Medication beliefs, reduction in adverse drug reaction (ADRs), Seizures frequency and medication related problems (MRPs) other than adverse drug reaction (ADRs) and overall quality of life of epileptic patients.

Registry
clinicaltrials.gov
Start Date
September 22, 2023
End Date
July 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matti Ullah

Assistant Professor

Hamdard University

Eligibility Criteria

Inclusion Criteria

  • Patients with confirmed diagnosis.
  • Patients treated for epilepsy with at least one anti epileptic drug, subjects willing to participate in the study with or without other severe co-morbidities were included in the study.

Exclusion Criteria

  • Pregnant female patients.
  • Patients who provide incomplete information
  • Patients with any terminal disease e.g., end stage renal disease
  • Patients not willing to participate were excluded from the study.

Outcomes

Primary Outcomes

Medication adherence

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.

Quality of life of Epileptic patients

Time Frame: 3 months

Patient's quality of life will be assessed using Quality of life for epilepsy scale(QOLIE-31). QOLIE-31(Quality of life in epilepsy) used for quality-of-life assessment which assess the patient's life's quality level along using anti-epileptic drug (AED) therapy through close ended questions with a score. The score can range from 0-100, with 100 representing the best quality of life.

Secondary Outcomes

  • Incidence of Adverse reactions(3 months)
  • Rate of seizures per week(3 months)
  • Incidence of Drug-Drug Interactions(3 months)

Study Sites (1)

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