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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06034353
• Other study ID #: NA0823
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: October 2023
• Source: Hamdard University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 385
• Est. completion date: March 15, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Shifa International Hospital	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Hamdard University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	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
Primary	Quality of life of Epileptic patients	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.	3 months
Secondary	Incidence of Drug-Drug Interactions	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.	3 months
Secondary	Incidence of Adverse reactions	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 months
Secondary	Rate of seizures per week	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.	3 months