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

Primary Purpose

SARS-COV2, COVID19

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaire
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS-COV2 focused on measuring SARS-COV2, functionnal complaints, sequel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier du MansRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient hospitalized between march 1 and june 30, 2020

Arm Description

patient hospitalized between march 1 and june 30, 2020

Outcomes

Primary Outcome Measures

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"
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)"
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
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)"

Secondary Outcome Measures

description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Modified Medical Research Council"
description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
description of functionnal and psychosocial complaints
complaints will be assessed by FRIED criteria
description of functionnal and psychosocial complaints
complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Identify the factors favoring the persistence of complaints
Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire"Modified Medical Research Council"
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by FRIED criteria
Describe functional, neuropsychological and social complaints at a distance
Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Describe the needs for medical and surgical consultations after discharge from hospital
Medical and surgical consultations after discharge will be measured as percentage
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
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.

Full Information

First Posted
September 9, 2020
Last Updated
March 8, 2022
Sponsor
Centre Hospitalier le Mans
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1. Study Identification

Unique Protocol Identification Number
NCT04561154
Brief Title
Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV
Acronym
REPERCOV
Official Title
Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-COV2, COVID19
Keywords
SARS-COV2, functionnal complaints, sequel

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient hospitalized between march 1 and june 30, 2020
Arm Type
Experimental
Arm Description
patient hospitalized between march 1 and june 30, 2020
Intervention Type
Other
Intervention Name(s)
questionnaire
Intervention Description
three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology
Primary Outcome Measure Information:
Title
Identify functionnal and psychosocial complaints
Description
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"
Time Frame
3 months after last hospitalization
Title
Identify functionnal and psychosocial complaints
Description
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)"
Time Frame
3 months after last hospitalization
Title
Identify functionnal and psychosocial complaints
Description
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
Time Frame
3 months after last hospitalization
Title
Identify functionnal and psychosocial complaints
Description
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)"
Time Frame
3 months after last hospitalization
Secondary Outcome Measure Information:
Title
description of functionnal and psychosocial complaints
Description
complaints will be assessed by questionnaire "Modified Medical Research Council"
Time Frame
3 months after last hospitalization
Title
description of functionnal and psychosocial complaints
Description
complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"
Time Frame
3 months after last hospitalization
Title
description of functionnal and psychosocial complaints
Description
complaints will be assessed by FRIED criteria
Time Frame
3 months after last hospitalization
Title
description of functionnal and psychosocial complaints
Description
complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Time Frame
3 months after last hospitalization
Title
Identify the factors favoring the persistence of complaints
Description
Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization
Time Frame
3 months after last hospitalization
Title
Describe functional, neuropsychological and social complaints at a distance
Description
Complaints will be assessed by questionnaire"Modified Medical Research Council"
Time Frame
3 months after last hospitalization
Title
Describe functional, neuropsychological and social complaints at a distance
Description
Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"
Time Frame
3 months after last hospitalization
Title
Describe functional, neuropsychological and social complaints at a distance
Description
Complaints will be assessed by FRIED criteria
Time Frame
3 months after last hospitalization
Title
Describe functional, neuropsychological and social complaints at a distance
Description
Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"
Time Frame
3 months after last hospitalization
Title
Describe the needs for medical and surgical consultations after discharge from hospital
Description
Medical and surgical consultations after discharge will be measured as percentage
Time Frame
3 months after last hospitalization
Title
Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.
Description
neuropsychological support, dietetics, social assistance after discharge will be measured as percentage
Time Frame
3 months after last hospitalization
Title
Describe the factors of inequalities in access to care
Description
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.
Time Frame
3 months after last hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle JADEAU
Phone
0243434343
Ext
37482
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hikombo HITOTO
Phone
0243434343
Email
hhitoto@ch-lemans.fr
Facility Information:
Facility Name
Centre Hospitalier du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JADEAU
Phone
0243434343
Ext
37482
Email
cjadeau@ch-lemans.fr
First Name & Middle Initial & Last Name & Degree
Hikombo HITOTO
Phone
0243434343
Email
hhitoto@ch-lemans.fr

12. IPD Sharing Statement

Learn more about this trial

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

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