Observational Study to Assess the Quality of Life of the Caregivers of Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Impact of MS on QoL of subjects diagnosed with multiple sclerosis (MS) and their caregivers
研究概览
简要总结
This is an observational, non controlled, non-interventional, multicentric, prospective study planned to be conducted in 450 subjects diagnosed with MS and their caregivers in 20 centres of Argentina. The observations from this study will contribute to the awareness of the impact on the Quality of Life (QoL) of the caregivers and, eventually will also provide measures for helping the subjects with multiple sclerosis (MS) without leaving aside the care of the physical and psychic health of those who work as caregivers.
详细描述
Caregivers of subjects diagnosed with MS have to take care of many activities of MS subjects that they cannot perform themselves, because of their lack of autonomy. The fact of aiding a person with some degree of disability due to a chronic disease in an intense way and for a long time could generate a high level of satisfaction in the caregiver; but at the same time the emotional and physical exhaustion of the caregiver increases as the disease progresses. The QoL of the person who is emotionally bonded to the MS subject as a caregiver has a great chance to be affected; and this is for sure more likely than in the case when the caregiver is a hired professional.
OBJECTIVES
Primary objective:
- To identify the impact of MS on the QoL of the MS subjects and their caregivers
Secondary objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS subjects and their caregivers, >21 years of age of both sexes
- •Subjects who have signed informed consent
- •Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 with at least 1 year of evolution
- •Subjects with MS that have an identified caregiver
排除标准
- •Subjects with other(s) associated neurological, psychiatric or systemic disease(s)
结局指标
主要结局
Impact of MS on QoL of subjects diagnosed with multiple sclerosis (MS) and their caregivers
时间窗: Each visit starting from the initial visit (Day 0) to end of the observation period (i.e. 24 months)
SF-36 will be administered to subjects diagnosed with MS and their caregivers; Beck depression inventory and MS-Functional system scores to subjects diagnosed with MS.
次要结局
- Correlation between QoL of subjects with MS and their caregivers(During the observation period of 24 months starting from the initial visit (i.e. Day 0))
- Predictors of QoL of caregivers(During the observation period of 24 months starting from the initial visit (i.e. Day 0))