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

NCT05520047 | Completed

• 1 other identifier: 2022-02Obs-CHRMT
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quality of life at 2 years in patients hospitalized in the Critical Care Unit for COVID-19

  The quality of life score at 2 years is assessed using the European Quality of Life 5 Dimensions and 5 Lines (EQ-5D-5L) questionnaire: it is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. 5 dimensions of the EQ-5D-5L scale. The dimensions assessed are: mobility, autonomy, impact on daily activities, pain and discomfort, and anxiety and depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  2 years after hospitalization for severe COVID-19

Secondary Outcomes (8)

• Dyspnea in patients hospitalized in the Critical Care Unit for COVID-19 using Modified Medical Research Council (mMRC) Dyspnea Scale

  2 years after hospitalization for severe COVID-19

• Mortality in patients hospitalized in the Critical Care Unit for COVID-19

  2 years after hospitalization for severe COVID-19

• Satisfaction/quality of life in patients hospitalized in the Critical Care Unit for COVID-19

  2 years after hospitalization for severe COVID-19

• Posttraumatic stress in patients hospitalized in the Critical Care Unit for COVID-19

  2 years after hospitalization for severe COVID-19

• Cognitive impact in patients hospitalized in the Critical Care Unit for COVID-19 using The Montreal Cognitive Assessment (MoCA)- BLIND questionnaire

  2 years after hospitalization for severe COVID-19

Study Arms (2)

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

Behavioral: COVID19-severe Patient

family of COVID19-severe Patient

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

Behavioral: family of COVID19-severe Patient

Interventions

COVID19-severe Patient BEHAVIORAL

Behavioral and social test assessment

COVID19-severe Patient

family of COVID19-severe Patient BEHAVIORAL

Behavioral and social test assessment

family of COVID19-severe Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 severe patients

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

COVID-19; Stress Disorders, Post-Traumatic; Cognitive Dysfunction; Social Behavior

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavior

Study Officials

• Damien BARRAUD, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 29, 2022
• Study Start: October 10, 2022
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)