NCT02547389已完成不适用
Enhancing Medical Compliance and Health-related Quality of Life of Patients With Epilepsy: Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 主要终点
- Compliance with taking prescribed medications
研究概览
简要总结
Improving medical compliance and health-related quality of life (HRQoL) among people with epilepsy (PWE) has become the focus of various treatment programs and behavioral interventions which continue to be challenging to both patients and health care professionals.
In order to design an effective intervention on the management of epilepsy, the drug management of epilepsy by community health workers was evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must have a definitive diagnosis of epilepsy for at least 6 months, based on the clinical judgement of the investigators. Epilepsy is defined by two or more unprovoked seizures. Clinical history, electroencephalography, and imaging data are all instrumental in rendering a formal decision. The seizure type, frequency, or severity are not criteria for exclusion, although this information will be recorded.
- •Patients must have a seizure frequency of at least two seizures in a 6 month period of time.
- •Patients must be on at least one anti-epileptic medication.
- •Patients must be able to report seizure frequency with either a paper or electronic diary.
- •Patients must be able to read and understand either English or Hindi.
- •Patients must be able to complete questionnaires and provide informed consent to this study.
排除标准
- •A diagnosis of psychogenic nonepileptic seizures
- •Severe depression, anxiety, or psychosis
- •Recent problem with substance abuse.
结局指标
主要结局
Compliance with taking prescribed medications
时间窗: 12 months
Assessment of compliance with taking medications at regularly scheduled intervals
次要结局
- Seizure frequency per month(change from baseline to 12 months in number of seizures per month assessed by patients diary)
- Quality of Life (Malay Quality of Life in Epilepsy Inventory-30)(change from baseline to 12 months in quality of life assessed by Malay Quality of Life in Epilepsy Inventory-30)
研究者
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