Enhancing Antiepileptic Drug Adherence

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165306
• Other study ID #: 214588
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: February 5, 2015
• Start date: June 2014

Study information

• Verified date: February 2015
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Epilepsy

Intervention

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
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Qazvin University of Medical Sciences, Shahid Rajaei Hospital	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Changes in coping planning		Changes from baseline, 3 Months and 6 months after the intervention	Yes
Secondary	Changes in quality of life		Changes from baseline, 3 Months and 6 months after the intervention	Yes
Secondary	Changes in habit strength		Changes from baseline, 3 Months and 6 months after the intervention	Yes
Secondary	Changes in Seizure Severity		Changes from baseline, 3 Months and 6 months after the intervention	Yes