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

NCT06034353 | Completed

• 1 other identifier: NA0823
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

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. 1.If pharmacist-led cognitive behavioral therapy can help in improving patient medication adherence?
2. 2.How will the cognitive behavioral therapy impact the quality of life of the patients?

Conditions

Epilepsy

Keywords

Cognitive behavioral therapy; Pharmacist; Medication Adherence; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Incidence of Drug-Drug Interactions

  3 months

• Incidence of Adverse reactions

  3 months

• Rate of seizures per week

  3 months

Study Arms (2)

Basic group

ACTIVE COMPARATOR

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.

Behavioral: Pharmacist-led Cognitive Behavioral therapy

Advanced

EXPERIMENTAL

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

Behavioral: Pharmacist-led Cognitive Behavioral therapy

Interventions

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.

Advanced; Basic group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Shifa International Hospital

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Epilepsy; Medication Adherence

Condition Hierarchy (Ancestors)

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

Study Officials

• Matti Ullah, PhD

  Hamdard University Islamabad Campus

  STUDY DIRECTOR

• Iqra Farooq, MPhil

  Shifa International Hospital

  PRINCIPAL INVESTIGATOR

• Muhammad Shafiq, BS. (Hons.)

  Subhan Medical Trust

  STUDY CHAIR

• Emmama Jamil, MPhil

  Hamdard University Islamabad Campus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 13, 2023
• Study Start: September 22, 2023
• Primary Completion: May 20, 2024
• Study Completion: July 15, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

PA (1)