跳至主要内容
临床试验/NCT02855970
NCT02855970已完成不适用

Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2015年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
responses to a quality of life questionnaire

研究概览

简要总结

The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation.

The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice.

The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •Patients aged 18 years and older.
  • •Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort.
  • •Patients who have provided oral informed consent.
  • •Patients with national health insurance cover

排除标准

  • •History of symptomatic stroke.
  • •Meningeal haemorrhage.
  • •Severe visual or hearing handicap making it difficult to complete the questionnaire.
  • •Global severe aphasia and mutism making communication with the patient impossible-.
  • •Unable to read or speak French.
  • •Dementia prior to the stroke.
  • •Psychiatric disorders and dependence on alcohol/drugs.
  • •Bedridden before the stroke.
  • •Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.

研究组 & 干预措施

patient

Experimental

干预措施: completion of a quality of life questionnaire (Other)

结局指标

主要结局

responses to a quality of life questionnaire

时间窗: Change compared with baseline score at Day 15, Day 60

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验