Quality of Life Evaluation With the SRI Questionnaire of ALS Patient With Non-invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- SRI questionnaire in patients who have indication for starting NIV
研究概览
简要总结
This study aims to measure the quality of life of ALS patients by the SRI questionnaire, in two distinct patient groups : Patient requiring initiation of NIV, and patients 24 hours dependent on NIV
This study also seeks to assess the quality of life of the caregivers with the Zarit Burden interview in those two populations
详细描述
The course of the study is as follows:
Patient newly ventilated with NIV :
inclusion is done on the day of starting NIV. On the day of inclusion: Clinical examination, completion of the ALS-FRS score, completion of the SRI score.
For the caregiver: Completion of the Zarit Burden Inerview Reassessment of scores (SRI, Zarit-burden, ALS-FRS), at three-month and six-month follow-up
Patient dependent of NIV :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •18 years or more
- •Patient followed for ALS probable or certain with Awaji criteria
- •group 1 : severe chronic respiratory failure, with a decision by the attending physician to start NIV
- •group 2 : complete dependence on NIV
- •Caregivers :
- •18 years or more
- •Informed and does not object to the study
- •Primary caregiver for more than 3 months of an ALS patient on NIV (either at initiation or with 24 hours NIV dependence)
- •More than 30 hours spent at home per week
- •Met the inclusion criteria for group 1 (NIV initiation) or group 2 (24 hours NIV dependence)
排除标准
- •Patient under legal protection/ guardianship
- •insufficient command of French
- •Severe cognitive impairment, particularly in relation to frontotemporal degeneration
- •No indication criteria for NIV.
- •Caregivers :
- •insufficient command of French
- •Caregiver of a patient with another chronic pathology
结局指标
主要结局
SRI questionnaire in patients who have indication for starting NIV
时间窗: six months
SRI questionnaire assessment at initiation of NIV, at 3-month follow-up and at 6-month follow-up
次要结局
- SRI of patients with total ventilatory dependence in ALS(three months)
- Zarit burden interview in both groups(Six months)