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临床试验/NCT04492761
NCT04492761Unknown不适用

Family Impact of Polyhandicap: Mixed Methodological Approach

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
260
试验地点
1
主要终点
Qualite of life

研究概览

简要总结

Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old
  • Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old
  • Written consent signed by caregivers for participation

排除标准

  • caregivers refusing to participate

结局指标

主要结局

Qualite of life

时间窗: 5 years

WHOQOL-Bref

次要结局

  • interview content(2 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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