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

Study Overview
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Brief Summary
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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.

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

Conditions
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SARS-COV2, COVID19

Intervention / Treatment
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* Other: questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention 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<br>patient hospitalized between march 1 and june 30, 2020 | Other: questionnaire<br>* three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology<br>|

What is the study measuring?
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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 questionnaireModified Medical Research Council | 3 months after last hospitalization | 
| Describe functional, neuropsychological and social complaints at a distance | Complaints will be assessed by questionnaireMedical 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sequel, SARS-COV2, functionnal complaints