An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
研究概览
简要总结
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.
详细描述
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Outpatients
- •Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen.
- •Able and willing to give the written informed consent (to be obtained before any study assessment)
- •For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition.
排除标准
- •Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug)
- •Hospital record data on epilepsy not available in the Investigator's files
- •Patient unable to fill in self-questionnaires (quality of life instrument)
- •Patient currently hospitalized
- •Patient who, according to the Investigator's judgment, is not able to follow the study procedures
结局指标
主要结局
total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
时间窗: 9 months: a 3-month retrospective and a 6-month prospective.
次要结局
- The primary endpoint is the total cost (direct and indirect) per patient per year of controlled patients collected in the retrospective and in the prospective phase.(9 months. a 3-month retrospective and a 6-month prospective.)
- the difference between the group of drug-resistant patients and the control group as regards each single resource consumptions and the direct and indirect costs (single and total)(9 months: a 3-month retrospective and a 6-month prospective.)
- The comparison of the seven multi-item scores and the overall score of QOLIE-31 (Quality of life in Epilepsy -31 items) questionnaire between the two patients groups(questionnaire administerd at visit 1 only)