Clinical trial NCT06034353: Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
Official title: Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Cognitive behavioral therapy
Pharmacist
Medication Adherence
Quality of life
Lead sponsor: Hamdard University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 385
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Medication adherence
timeFrame: 3 months
measure: Quality of life of Epileptic patients
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of Drug-Drug Interactions
timeFrame: 3 months
measure: Incidence of Adverse reactions
timeFrame: 3 months
measure: Rate of seizures per week
timeFrame: 3 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa International Hospital
Study officials:
affiliation: Hamdard University Islamabad Campus
name: Matti Ullah, PhD
role: STUDY_DIRECTOR
affiliation: Shifa International Hospital
name: Iqra Farooq, MPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Subhan Medical Trust
name: Muhammad Shafiq, BS. (Hons.)
role: STUDY_CHAIR
affiliation: Hamdard University Islamabad Campus
name: Emmama Jamil, MPhil
role: STUDY_CHAIR
References: