Enhancing Antiepileptic Drug Adherence
Not Applicable
Completed
- Conditions
- Epilepsy
- Interventions
- Behavioral: Motivational Interviewing (MI)Behavioral: Routine counseling
- 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
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
- Arm && Interventions
Group Intervention Description Intervention Motivational Interviewing (MI) Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence Active Comparator Routine counseling Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.
- 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