Enhancing Antiepileptic Drug Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- changes in Patient-reported medication Adherence to antiepileptic drugs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Patients enrolled in the intervention arm will receive two educational sessions on the importance of medication and barriers to adherence
干预措施: Motivational Interviewing (MI) (Behavioral)
Active Comparator
Usual Care The usual care group received routine counseling performed by the neurologist/neurosurgeon and nurses.
干预措施: Routine counseling (Behavioral)
结局指标
主要结局
changes in Patient-reported medication Adherence to antiepileptic drugs
时间窗: 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
次要结局
- Changes in action planning(Changes from baseline, 3 Months and 6 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)
- 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)
研究者
Amir H Pakpour
vice chancellor for research
Qazvin University Of Medical Sciences