Enhancing Antiepileptic Drug Adherence

Study Overview
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Brief Summary
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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.

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Behavioral: Routine counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence | Behavioral: Motivational Interviewing (MI)<br>* 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<br>* Other names: facilitate behavior change;|
| Active Comparator: Active Comparator<br>Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses. | Behavioral: Routine counseling<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy