Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV (REPERCOV)

Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV

Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).

It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.

Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.

In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.

The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

Study Overview

• Status: Recruiting
• Conditions: COVID19; SARS-COV2
• Intervention / Treatment: Other: questionnaire

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christelle JADEAU; Phone Number: 37482 0243434343; Email: cjadeau@ch-lemans.fr
• Study Contact Backup: Name: Hikombo HITOTO; Phone Number: 0243434343; Email: hhitoto@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier Du Mans
    • Contact: Christelle JADEAU; Phone Number: 37482 0243434343; Email: cjadeau@ch-lemans.fr
    • Contact: Hikombo HITOTO; Phone Number: 0243434343; Email: hhitoto@ch-lemans.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient hospitalized for severe Covid-19 infection between March 1 and June 30, 2020 in a conventional unit, intensive care unit, at the Centre hospitalier du Mans and alive at the time of the investigation at 2 to 3 months
• Patient having given their express consent, after having received the research information letter upon discharge from hospital or having given their express consent after sending the information letter
• Age ≥ 18 years
• Patient having contracted a SARS-CoV-2 infection proved by RT-PCR and / or retrospective serology and / or a Covid-19 syndrome with suggestive chest scanner (during the period from March 1, 2020 to June 30, 2020)

Exclusion Criteria:

• Patient opposition to participate in the cohort
• Non-French speaking patient
• Patients who cannot read or write
• Patient subject to a protective measure
• Patient not affiliated to a social security or equivalent health insurance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient hospitalized between march 1 and june 30, 2020	Other: questionnaire; three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"	3 months after last hospitalization
Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria	3 months after last hospitalization
Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Modified Medical Research Council"	3 months after last hospitalization
description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
description of functionnal and psychosocial complaints	complaints will be assessed by FRIED criteria	3 months after last hospitalization
description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization
Identify the factors favoring the persistence of complaints	Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization	3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire"Modified Medical Research Council"	3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by FRIED criteria	3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization
Describe the needs for medical and surgical consultations after discharge from hospital	Medical and surgical consultations after discharge will be measured as percentage	3 months after last hospitalization
Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.	neuropsychological support, dietetics, social assistance after discharge will be measured as percentage	3 months after last hospitalization
Describe the factors of inequalities in access to care	Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint.	3 months after last hospitalization

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): June 11, 2021
• Study Completion (Anticipated): June 11, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: SARS-COV2; functionnal complaints; sequel
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CHM-2020/S10/04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No