Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Caregivers quality of life
研究概览
简要总结
The studies conducted so far concerning the medical and paramedical cares provided to patients with profound and multiple disabilities (PMD) often show important limitations: samples are too small or very heterogeneous, generally constituted of children only; studies are mainly cross-sectional and retrospective, focusing on very specific issues instead of assessing health and quality of life from a more global perspective... So far, the investigators found no published data from a prospective cohort study involving a representative sample of patients with PMD. The present project aims to set up such a cohort so as to describe for the first time the natural history of French patients with PMD as well as the cares they receive at home or within the different dedicated structures in France. This cohort will also make it possible to identify the factors responsible for differences in the cares patients are provided, the consequences of these differences on their health and their quality of life (and those of their relatives) as well as the evolutions of these data over time. It will then allow for assessing the effectiveness of the French healthcare system to care for patients with PMD as well as building a frame of reference regarding the best cares to provide to these patients.
The primary goal of this study is to identify the determinants of health among patients with PMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 3 years old,
- •patient with health insurance,
- •causal brain injury before the age of 3,
- •Intellectual Quotient < 40 or not assessable,
- •motor disability: paraparesis, tetraparesis, hemiparesis, ataxia, neuromuscular disorders, or extrapyramidal motor disorders,
- •score at the Gross Motor Function Classification System > 3,
- •score at the Functional Independence Measure < 55.
排除标准
- •Subject declaring benefit "psychotropic treatment which" significantly alter the reasoning, discernment or judgment.
结局指标
主要结局
Caregivers quality of life
时间窗: 36 months
Assessment of quality of life from questionnaires,WHOQOL-Bref, Brief-COPE - Brief-COPE
次要结局
- emotional distress and subjective burden of natural caregivers,(36 months)
- burnout of institutional caregivers(36 months)