Measuring Consequences of Disability for Patients With Multiple Sclerosis and Caregivers on Economic Burden and Social Participation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 主要终点
- Annual average total health care cost of the Multiple Sclerosis by patient
研究概览
简要总结
The objective of this study is to measure economic burden of Multiple Sclerosis (MS) from a new point of view that includes consequences of disability on Quality Of Life (QOL), social participation and capabilities of patients and caregivers. To the investigators' knowledge, there is currently no data including intangible costs related to caregivers and calculating the overall economic cost of Multiple Sclerosis, particularly, in France.
详细描述
The goal of this study is to evaluate prospectively the economic burden of Multiple Sclerosis (MS) in France by calculating direct costs (medical and non-medical) and indirect costs and by estimating consequences of MS on utility (QALY) of patients and caregivers in a societal perspective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Participant aged 18 or more
- •Confirmed MS diagnosis (McDonald 2005)
- •Defined type of MS according classification of Lublin and Reingold
排除标准
- •Subject living in an institution
- •Severe cognitive dysfunction preventing to answer questionnaire
- •Subject already included in other clinical study (phase 1 to 3)
结局指标
主要结局
Annual average total health care cost of the Multiple Sclerosis by patient
时间窗: 1 year
Global cost of Multiple Sclerosis considering direct medical and non-medical costs as well as the indirect and intangible costs associated to the patient-caregiver
次要结局
- Score of social participation(1 year)
- Validity of life quality measurement EQ-5D(1 year)
- Utilities measured by the Short Form-6D (SF-6D)(1 year)
- QALY(1 year)