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临床试验/NCT03865173
NCT03865173Unknown不适用

Post-stroke Pathway: Analysis and Link With One Year Sequelae in a French Cohort of Stroke Patients

University Hospital, Bordeaux13 个研究点 分布在 1 个国家目标入组 1,138 人开始时间: 2019年11月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,138
试验地点
13
主要终点
Modified Rankin Scale (mRS) Score

研究概览

简要总结

The link between post-stroke pathways and patient sequelae have not yet been clearly defined. The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode.

详细描述

Stroke is a serious health event, involving the entire health care system and generating considerable socioeconomic weight for society. Knowledge of the components, the diversity and the scalability of post-stroke life pathways is currently not sufficient. Moreover the link between post-stroke pathways and patient sequelae have not yet been clearly defined.

The main purpose is to identify the post-stroke life pathways components associated with sequalae at 3 months and 1 year after the acute stroke episode. The secondary objectives are: 1) To define a typology of the life pathways of stroke patients, , 2) To analyze the social and geographical inequalities in the management of stroke, 4) To estimate the cost of the pathway elements of stroke management; 5) Measure the sequelae of stroke patients at three months and one year after the acute episode.

The design is a prospective multicenter cohort study with a follow up to 1 year after the acute episode, managed in several hospitals in the Aquitaine region (France).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient being over 18 years of age living in metropolitan France;
  • Patient with recent stroke (not before 2019) whose diagnosis confirmed by a neuro-vascular physician;
  • Patient managed for stroke in one of the 13 participating hospitals of the Aquitaine region;
  • Patient giving consent to participate to PAPASéPA;
  • Patient to be alive at the end of the acute management hospital stay

排除标准

  • Patient refuse to participate to PAPASéPA
  • Patient died during the initial stay

结局指标

主要结局

Modified Rankin Scale (mRS) Score

时间窗: 1 year

Activity limitations post-stroke measure Minimum score : 0 "no symptom" Maximum score : 6 "death"

次要结局

  • Telephone Interview for Cognitive Status Modified (TICS) Score(1 year)
  • Hospital anxiety and depression scale (HADS) Score(1 year)
  • Fatigue Severity Scale (FSS) Score(1 year)
  • Barthel Index (BI) Score(1 year)
  • Community Integration Questionnaire (CIQ-R) Score(1 year)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (13)

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