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

Not Applicable

• Conditions: SARS-COV2; COVID19
• Interventions: Other: questionnaire

• Registration Number: NCT04561154
• Lead Sponsor: Centre Hospitalier le Mans

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-11
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-23
• Primary Completion: 2021-06-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Study Completion: 2022-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient hospitalized between march 1 and june 30, 2020	questionnaire	patient hospitalized between march 1 and june 30, 2020

Primary Outcome Measures

Name	Time	Method
Identify functionnal and psychosocial complaints	3 months after last hospitalization	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)"

Secondary Outcome Measures

Name	Time	Method
Describe the needs for medical and surgical consultations after discharge from hospital	3 months after last hospitalization	Medical and surgical consultations after discharge will be measured as percentage
Describe the factors of inequalities in access to care	3 months after last hospitalization	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.
description of functionnal and psychosocial complaints	3 months after last hospitalization	complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Describe functional, neuropsychological and social complaints at a distance	3 months after last hospitalization	Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.	3 months after last hospitalization	neuropsychological support, dietetics, social assistance after discharge will be measured as percentage
Identify the factors favoring the persistence of complaints	3 months after last hospitalization	Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization

Trial Locations

Locations (1)

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France