Clinical trial NCT05520047: Long-term Quality of Life and Prognostic Factors in Severe COVID-19 Patients and Their Relatives
Official title: Assessment and Prognostic Factors of Long-term Quality of Life of Patients Hospitalized With Severe COVID-19 and Their Relatives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Quality of Life
Posttraumatic Stress Disorder
Cognitive Impairment
Social Behavior
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 severe patients

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Having stayed in a critical care unit (resuscitation, continuous monitoring, intensive care) at the Regional Hosiptal Center (CHR) Metz-Thionville for COVID-19 between March 2020 and March 2022
* Having given their oral consent to participate (telephone contact), or not having objected during their lifetime to the use of their hospital data for epidemiological research (deceased patients)
* The trusted person or closest family member will also be invited to participate.
* The patients included will be those who were hospitalized in conventional critical care services, but also in functional units of so-called "ephemeral" critical care, armed in emergency in the context of a massive influx of victims (Cardiological Intensive Care, Post-Interventional Monitoring Room in the operating room, Dialysis Center).

Exclusion Criteria:

* Patient under guardianship or deprivation of liberty
* Cognitive disorders or lack of French language skills preventing response to evaluation questionnaires

Primary outcomes:
measure: Quality of life at 2 years in patients hospitalized in the Critical Care Unit for COVID-19
timeFrame: 2 years after hospitalization for severe COVID-19
Secondary outcomes:
measure: Dyspnea in patients hospitalized in the Critical Care Unit for COVID-19 using Modified Medical Research Council (mMRC) Dyspnea Scale
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Mortality in patients hospitalized in the Critical Care Unit for COVID-19
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Satisfaction/quality of life in patients hospitalized in the Critical Care Unit for COVID-19
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Posttraumatic stress in patients hospitalized in the Critical Care Unit for COVID-19
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Cognitive impact in patients hospitalized in the Critical Care Unit for COVID-19 using The Montreal Cognitive Assessment (MoCA)- BLIND questionnaire
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Social and professional impact in patients hospitalized in the Critical Care Unit for COVID-19 using Lawton INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (IADL)
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using the impact of event scale-revised (IES-R) questionnaire
timeFrame: 2 years after hospitalization for severe COVID-19
measure: Post-traumatic stress in the family of patients hospitalized in the Critical Care Unit for COVID-19 using Hospital Anxiety and Depression Scale (HADS) questionnaire
timeFrame: 2 years after hospitalization for severe COVID-19
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Damien BARRAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: