Enhancing Antiepileptic Drug Adherence

More than half of patients with epilepsy achieve full control of their seizures with antiepileptic drugs (AEDs).The study is aimed to investigate effectiveness of an educational intervention in improving medication adherence in patients with epilepsy.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Motivational Interviewing (MI); Behavioral: Routine counseling

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of
    • Qazvin University of Medical Sciences, Shahid Rajaei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of epilepsy according to the International League Against Epilepsy criteria
• age equal or higher than 18 years
• independence in daily living activities
• absence of major cognitive impairment or active psychiatric disorders

Exclusion Criteria:

• presence of a rapidly progressing neurological or medical disorder
• patients not receiving anti-epileptic drugs
• a history of significant substance abuse within the past year
• a diagnosis of mental retardation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence	Behavioral: Motivational Interviewing (MI); A multifaceted intervention program was used to improve adherence and clinical outcomes in epileptic patients. However, this study mainly focused on behavioral treatment in the patients. Patient's intervention A three-week session will perform to improve medication adherence in patients in the intervention group. Face to face introductory motivational interviews (MI) will conduct to resolve patient ambivalence about change. Besides providingthe intervention for the patients, the health care team and the patient's family member will receive a brief intervention.All GPs and nurses as well as patients' family members participate in a single session MI with the same procedure; Other Names: facilitate behavior change
Active Comparator: Active Comparator; Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.	Behavioral: Routine counseling; All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 5 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in Patient-reported medication Adherence to antiepileptic drugs	The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to antiepileptic drugs	changes from baseline , 3 Months and 6 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in serum levels of antiepileptic drugs	Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity	changes from baseline , 6 Months, 12 months and 18 months after the interventio
Changes in psychological predictors of medication adherence (intention, perceived behavioral control and Self-monitoring)		Changes from baseline, 3 Months and 6 months after the intervention
Changes in action planning	The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention	Changes from baseline, 3 Months and 6 months after the intervention
Changes in coping planning		Changes from baseline, 3 Months and 6 months after the intervention
Changes in quality of life		Changes from baseline, 3 Months and 6 months after the intervention
Changes in habit strength		Changes from baseline, 3 Months and 6 months after the intervention
Changes in Seizure Severity		Changes from baseline, 3 Months and 6 months after the intervention

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences
• Investigators: Principal Investigator: Amir H Pakpour, PhD, Qazvin University of Medical Sciences

Publications and helpful links

General Publications

• Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10:CD008312. doi: 10.1002/14651858.CD008312.pub4.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 214588