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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Ile De France
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Paris, Ile De France, France, 75013
- GH Pitié Salpêtrière - Charles Foix
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Transversale
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Prevalence of post-traumatic stress at 1 year
Délai: 12 months from hospitalization
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Level of depression at 1 year
Délai: 12 months from hospitalization
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Assessed by the Center for Epidemiologic Studies Depression scale (CES-D, minimum value: 0, maximum value: 60, higher score indicates a worse outcome)
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12 months from hospitalization
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Perceived interest of the proposed communication tools at 1 year
Délai: 12 months from hospitalization
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Semi-structured interviews
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12 months from hospitalization
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Level of quality of life at 1 year
Délai: 12 months from hospitalization
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Assessed by EQ-5D (EuroQol 5Dimension scale, minimum value: 0, maximum value: 100, higher score indicates a better outcome)
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12 months from hospitalization
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Claire FAZILLEAU, Assistance Publique - Hôpitaux de Paris
- Chercheur principal: Arthur Dr JAMES, MD, Assistance Publique - Hôpitaux de Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- APHP200450
- 2020-A03430-39 (Autre identifiant: IDRCB)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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