Epilepsy Prevalence and Intervention Study in Zhejiang Province, China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Occurrence of refractory epilepsy
研究概览
简要总结
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention to help patients with epilepsy to improve seizure control and the quality of life.
详细描述
To carry out the epidemiological investigation on epilepsy in Zhejiang Province, China, and then establish early comprehensive intervention（proper antiepileptic drugs and education intervention） to help patients with epilepsy to improve seizure control and the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and untreated epilepsy; Aged 14 and above; Sign the informed consents.
排除标准
- •With intellectual development disorder; With serious heart and lung diseases.
研究组 & 干预措施
A: Routine AED group
Routine and proper antiepileptic drugs group
干预措施: routine and proper antiepileptic drugs (Drug)
B: AED and education group
Routine, proper antiepileptic drugs and education group
干预措施: education on epilepsy (Behavioral)
B: AED and education group
Routine, proper antiepileptic drugs and education group
干预措施: routine and proper antiepileptic drugs (Drug)
结局指标
主要结局
Occurrence of refractory epilepsy
时间窗: 24 months
occurrence of refractory epilepsy at 24 months
Change from baseline seizures frequency 1
时间窗: 12 months
change from baseline seizures frequency at 12 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
Change from baseline seizures frequency 2
时间窗: 24 months
change from baseline seizures frequency at 24 months, seizure frequency is defined as the number of seizure attacks during 3 months before baseline or endpoint)
次要结局
- Quality of life (QOL scales)(2 year)