Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care Unit (FAMILY-COVID)
Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.
During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.
The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.
研究概览
地位
条件
详细说明
The stay in the ICU is a complex and often traumatic experience for patients. Patients often develop psychiatric disorders such as anxiety, depression or post-traumatic stress disorder after an ICU stay. These symptoms can be prolonged over time, resulting in a decrease in quality of life and a potential cost in care.
In the epidemic context of the COVID crisis, the presence of family members in the intensive care unit was reduced to its most extreme portion, with sometimes an almost total impossibility of visiting a loved one. This situation, although it has become less strict, has lasted for a long time. The patient can only exchange with them with difficulty, despite the extremely trying situation that is resuscitation. Moreover, there is a stress factor linked to the infectious risk for the relatives and for the relatives with regard to COVID-19, in particular within the framework of family clusters with sometimes several hospitalized subjects within the same family.
Of course, means of communication have been put in place with relatives, but these means do not seem to be equivalent to the presence of one's relatives.
The investigators therefore hypothesize that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of patients and their relatives.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Ile De France
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Paris、Ile De France、法国、75013
- GH Pitié Salpêtrière - Charles Foix
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Major patients (above 18 years old)
- Admitted in intensive care unit
- Hospitalized more than 2 days (48 hours)
- Between 01/01/2020 and 06/30/2020
- Whether SARS-CoV-2 positive or negative
Exclusion Criteria:
- Minor patient
- Protected major (under safeguardship, curatorship or guardianship)
- Patient opposition
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:横截面
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of post-traumatic stress at 1 year
大体时间:12 months from hospitalization
|
Prevalence of post-traumatic stress in patients treated in intensive care at 1 year diagnosed with an IES-r> 33 depending on whether they are SARS-CoV-2 positive or not. (IES-r: Impact of Event Scale - Revised scale, minimum value: 0, maximum value: 88, higher score indicates a worse outcome) |
12 months from hospitalization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Level of depression at 1 year
大体时间:12 months from hospitalization
|
Assessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)
|
12 months from hospitalization
|
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Perceived interest of the proposed communication tools at 1 year
大体时间:12 months from hospitalization
|
Semi-structured interviews
|
12 months from hospitalization
|
|
Level of quality of life at 1 year
大体时间:12 months from hospitalization
|
Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)
|
12 months from hospitalization
|
合作者和调查者
调查人员
- 研究主任:Claire FAZILLEAU、Assistance Publique - Hôpitaux de Paris
- 首席研究员:Arthur Dr JAMES, MD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP200450
- 2020-A03430-39 (其他标识符:IDRCB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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