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

NCT ID: NCT05520047

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-08-29

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.

Conditions

COVID-19; Quality of Life; Posttraumatic Stress Disorder; Cognitive Impairment; Social Behavior

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID19-severe Patient

modified Medical Research Council dyspnea scale (mMRC), European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L), the impact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS), the Montreal Cognitive Assessment (MoCA)- BLIND, Lawton instrumental activities of daily living (IADL) and Return to work scales

COVID19-severe Patient

Intervention Type: BEHAVIORAL

Behavioral and social test assessment

family of COVID19-severe Patient

impact of event scale-revised (IES-R), The Hospital Anxiety and Depression Scale (HADS) scales

family of COVID19-severe Patient

Intervention Type: BEHAVIORAL

Behavioral and social test assessment

Interventions

COVID19-severe Patient

Behavioral and social test assessment

Intervention Type: BEHAVIORAL

family of COVID19-severe Patient

Behavioral and social test assessment

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damien BARRAUD, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital de Mercy

Locations

CHR Metz-Thionville/Hopital de Mercy

Metz, , France

Countries

France

Other Identifiers

2022-02Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id