Enhancing Antiepileptic Drug Adherence

Not Applicable

Completed

• Conditions: Epilepsy

• Registration Number: NCT02165306
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-17
• Primary Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in action planning	Changes from baseline, 3 Months and 6 months after the intervention	The number of planning strategies is used by the patients before, at baseline, three months and six months after the intervention
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 coping planning	Changes from baseline, 3 Months and 6 months after the intervention
changes in serum levels of antiepileptic drugs	changes from baseline , 6 Months, 12 months and 18 months after the interventio	Serum anti-epileptic drug (AED) level monitoring will be collected to assess AED adherence or toxicity
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

Trial Locations

Locations (1)

Qazvin University of Medical Sciences, Shahid Rajaei Hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of