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Clinical Trials/NCT04872049
NCT04872049
Unknown
Not Applicable

Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care

Assistance Publique - Hôpitaux de Paris1 site in 1 country264 target enrollmentApril 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
264
Locations
1
Primary Endpoint
Prevalence of post-traumatic stress at 1 year
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 27, 2021
End Date
October 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of post-traumatic stress at 1 year

Time Frame: 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)

Secondary Outcomes

  • Level of depression at 1 year(12 months from hospitalization)
  • Perceived interest of the proposed communication tools at 1 year(12 months from hospitalization)
  • Level of quality of life at 1 year(12 months from hospitalization)

Study Sites (1)

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