Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- monthly seizure frequency after 12 months
研究概览
简要总结
Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.
详细描述
Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Epileptic or psychogenic seizures
排除标准
- •patients who cannot provide informed consent and don't have a legal guardian
结局指标
主要结局
monthly seizure frequency after 12 months
时间窗: 12 months
monthly seizure frequency at the follow-up after 12 months
monthly seizure frequency after 6 months
时间窗: 6 months
monthly seizure frequency at the follow-up after 6 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
时间窗: 12 months
health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)
Seizure freedom
时间窗: 12 months
percentage of patients without epileptic seizures
interruption of status epilepticus
时间窗: 48 hours
percentage of patients with interrupted status epilepticus
次要结局
- Berlin Social Support Scales (BSSS)(24 months)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF)(24 months)
- Multidimensional Fatigue Inventory(24 months)
- Beck Depression Inventory II(24 months)
- Pittsburgh Sleep Quality Index(24 months)
- Resilience Scale 13(24 months)
研究者
Dr. Yaroslav Winter
Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center
Johannes Gutenberg University Mainz