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临床试验/NCT04385121
NCT04385121已完成不适用

Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))

研究概览

简要总结

The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

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

  • Family member of a Covid-19 positive patient hospitalized in Intensive Care Unit who gave his oral agreement following the communication of the notice of non-opposition.
  • A patient is considered to be Covid + if the RT-PCR is positive OR if characteristic images are taken with a chest scanner.
  • The family member included in the study is preferably the patient's support person. In the absence of an expression of the patient's will, he is the close referent designated by the family as an interlocutor.

排除标准

  • Difficulties in understanding French

结局指标

主要结局

Existence of a post-intensive care syndrome-family ((combined score of the HAD ( Hospital Anxiety and Dépression scale) and IES-R ( Impact of Event Scale-Revised) questionnaires))

时间窗: 3 months

An overall score of 19 or more indicates a major depressive episode (HAD) and a total score of 22 as in favor of significant symptoms of acute stress (IES-R)

次要结局

未报告次要终点

研究者

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

研究点 (1)

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