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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04872049
Other study ID # APHP200450
Secondary ID 2020-A03430-39
Status Active, not recruiting
Phase
First received
Last updated
Start date April 27, 2021
Est. completion date October 27, 2021

Study information

Verified date April 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 264
Est. completion date October 27, 2021
Est. primary completion date October 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France GH Pitié Salpêtrière - Charles Foix Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of post-traumatic stress at 1 year 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
Secondary Level of depression at 1 year 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
Secondary Perceived interest of the proposed communication tools at 1 year Semi-structured interviews 12 months from hospitalization
Secondary Level of quality of life at 1 year Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome) 12 months from hospitalization
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