Clinical Trials Directory

Trials / Completed

CompletedNCT05520047

Long-term Quality of Life and Prognostic Factors in Severe COVID-19 Patients and Their Relatives

Assessment and Prognostic Factors of Long-term Quality of Life of Patients Hospitalized With Severe COVID-19 and Their Relatives

Status
Completed
Phase
Study type
Observational
Enrollment
800 (actual)
Sponsor
Centre Hospitalier Régional Metz-Thionville · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

This is a prospective cohort study with multicenter retrospective data collection (CHR Metz-Thionville, Hôpital Mercy and Hôpital Bel Air). Patients hospitalized for COVID-19 in a critical care unit between March 2020 and March 2022 will be contacted by telephone 24 months after their hospitalization by a doctor or intern from the intensive care unit. If the patient agrees to participate, he or she will then complete the study questionnaire items. Data concerning their hospital management between their hospitalization for COVID-19 and the 24-month call will then be extracted from their medical records.

Detailed description

The first wave of the global SARSCoV2 pandemic in March and April 2020 hit many regions of the world hard, including our Grand Est region, which had to reorganize its healthcare system in an emergency and in an unprecedented manner. The morbidity and mortality linked to this 1st wave is already very high, with mortality in intensive care units reaching 40% in the most affected regions. Mortality, particularly in the short term, has long been the cornerstone of critical care evaluation. The development of resuscitation techniques in recent years has led to a substantial improvement in the survival of more and more patients, but also older and more polypathological patients. However, this hard criterion of mortality seems nowadays a little obsolete, making it prefer on the one hand the evaluation of the mortality in the longer term, but also and especially the evaluation of the quality of this survival. The interest has therefore shifted in recent years towards the long-term evaluation of criteria more focused on the patient but also on the family. Current data in pathologies such as Acute respiratory distress syndrome (ARDS) or severe sepsis concur to show that these are invariably associated with an alteration in quality of life, in all the domains of its original definition by the World Health Organization (WHO), and are at the origin of a "post-resuscitation syndrome". COVID19 is marked in 5 to 10% of cases by a severe septic picture, with multivisceral dysfunction, and pulmonary involvement in the foreground. The existence of so-called "long COVID" clinical pictures already described in the literature and the media, and especially the obvious arrival of a second wave and perhaps others, make it necessary to study the long-term prognosis of this emerging infection. The aim of this work is to quantify in a multimodal way the long-term quality of life of patients surviving a severe form of COVID19 and their families and to try to identify elements related to the patient, the COVID19, or the management, which predict this quality of survival. The theme concerned is on the one hand epidemiological and risk assessment for the populations, and on the other hand preventive and curative of late sequelae.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCOVID19-severe PatientBehavioral and social test assessment
BEHAVIORALfamily of COVID19-severe PatientBehavioral and social test assessment

Timeline

Start date
2022-10-10
Primary completion
2024-08-29
Completion
2024-08-29
First posted
2022-08-29
Last updated
2024-12-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05520047. Inclusion in this directory is not an endorsement.