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NCT Number: NCT06034353

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

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.

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Key information

Conditions

Epilepsy Behavior Brain Diseases Central Nervous System Diseases Health Behavior Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shifa International Hospital

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacist-led Cognitive Behavioral therapy

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.

Primary outcomes

  1. 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.

  2. 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

  1. Incidence of Drug-Drug Interactions

    Time frame: 3 months

    Drug interactions among epileptic and non-epileptic drug will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervation in both basic and advance groups.

  2. Incidence of Adverse reactions

    Time frame: 3 months

    Adverse reactions of all anti-epileptic drug will be noted while assessing a patient.

    It is used to access the reduction in frequency of Adverse drug reaction after pharmacist intervation in both basic and advance groups.

  3. Rate of seizures per week

    Time frame: 3 months

    While assessing patient no. of seizures per week is asked and noted by the pharmacist. After intervening both basic and advance group impact of intervation is accessed for no. of seizures in the groups.

Sponsors and collaborators

Lead sponsor

Hamdard University

Other

Registry information

Acronym: COGNIPHARM-I

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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