Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients (COGNIPHARM-I)

Hamdard University

Status: Completed

Conditions: Epilepsy

Treatments: Behavioral: Pharmacist-led Cognitive Behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06034353

NA0823

Details and patient eligibility

About

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.

Full 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.

Enrollment: 385 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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385 participants in 2 patient groups

Basic group

Active Comparator group

Description:

Lifestyle Modifications: General education about healthy life style and diet. Education : general awareness about disease and medication Pill Planner: Pill planner will be provided to keep them adherent to their medication Counselling: Counsel the patients about there medication dosage, frequency and appropriate time.

Treatment:

Behavioral: Pharmacist-led Cognitive Behavioral therapy

Advanced

Experimental group

Description:

Lifestyle Modifications: Specific education on keto-diet, yoga and meditation Education : Specific disease education targeting medication adverse drug reaction (ADR), seizure chart management Pill Planner: Pill planner will also be provided to this group Counselling: Cognitive Behavioral therapy will be provided

Treatment:

Behavioral: Pharmacist-led Cognitive Behavioral therapy