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

March 8, 2022 updated by: Centre Hospitalier le Mans

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Le Mans, France, 72000
        • Recruiting
        • Centre Hospitalier du Mans
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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 "Modified Medical Research Council"
3 months after last hospitalization
Identify functionnal and psychosocial complaints
Time Frame: 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 "Medical Outcome Study Short Form 36 (MOS SF-36)"
3 months after last hospitalization
Identify functionnal and psychosocial complaints
Time Frame: 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 FRIED criteria
3 months after last hospitalization
Identify functionnal and psychosocial complaints
Time Frame: 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)"
3 months after last hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
description of functionnal and psychosocial complaints
Time Frame: 3 months after last hospitalization
complaints will be assessed by questionnaire "Modified Medical Research Council"
3 months after last hospitalization
description of functionnal and psychosocial complaints
Time Frame: 3 months after last hospitalization
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
Time Frame: 3 months after last hospitalization
complaints will be assessed by FRIED criteria
3 months after last hospitalization
description of functionnal and psychosocial complaints
Time Frame: 3 months after last hospitalization
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
Time Frame: 3 months after last hospitalization
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
Time Frame: 3 months after last hospitalization
Complaints will be assessed by questionnaire"Modified Medical Research Council"
3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time Frame: 3 months after last hospitalization
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
Time Frame: 3 months after last hospitalization
Complaints will be assessed by FRIED criteria
3 months after last hospitalization
Describe functional, neuropsychological and social complaints at a distance
Time Frame: 3 months after last hospitalization
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
Time Frame: 3 months after last hospitalization
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.
Time Frame: 3 months after last hospitalization
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
Time Frame: 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.
3 months after last hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier le Mans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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