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

NCT ID: NCT06034353

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2024-07-15

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.

Study Groups

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Basic group

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.

Group Type ACTIVE_COMPARATOR

Pharmacist-led Cognitive Behavioral therapy

Intervention Type 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.

Advanced

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

Group Type EXPERIMENTAL

Pharmacist-led Cognitive Behavioral therapy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamdard University

OTHER

Sponsor Role lead

Responsible Party

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Matti Ullah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matti Ullah, PhD

Role: STUDY_DIRECTOR

Hamdard University Islamabad Campus

Iqra Farooq, MPhil

Role: PRINCIPAL_INVESTIGATOR

Shifa International Hospital

Muhammad Shafiq, BS. (Hons.)

Role: STUDY_CHAIR

Subhan Medical Trust

Emmama Jamil, MPhil

Role: STUDY_CHAIR

Hamdard University Islamabad Campus

Locations

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Shifa International Hospital

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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NA0823

Identifier Type: -

Identifier Source: org_study_id

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