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

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ClinicalTrials.gov Identifier: NCT04561154
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

Study Description
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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.


Condition or disease Intervention/treatment Phase
SARS-COV2 COVID19 Other: questionnaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV
Actual Study Start Date : June 11, 2020
Actual Primary Completion Date : June 11, 2021
Estimated Study Completion Date : June 11, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patient hospitalized between march 1 and june 30, 2020
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


Outcome Measures
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Primary Outcome Measures :
  1. 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"

  2. 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. 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

  4. 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)"


Secondary Outcome Measures :
  1. description of functionnal and psychosocial complaints [ Time Frame: 3 months after last hospitalization ]
    complaints will be assessed by questionnaire "Modified Medical Research Council"

  2. 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. description of functionnal and psychosocial complaints [ Time Frame: 3 months after last hospitalization ]
    complaints will be assessed by FRIED criteria

  4. 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)"

  5. 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

  6. 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"

  7. 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)"

  8. Describe functional, neuropsychological and social complaints at a distance [ Time Frame: 3 months after last hospitalization ]
    Complaints will be assessed by FRIED criteria

  9. 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)"

  10. 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

  11. 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

  12. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04561154


Contacts
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Contact: Christelle JADEAU 0243434343 ext 37482 cjadeau@ch-lemans.fr
Contact: Hikombo HITOTO 0243434343 hhitoto@ch-lemans.fr

Locations
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France
Centre Hospitalier du Mans Recruiting
Le Mans, France, 72000
Contact: Christelle JADEAU    0243434343 ext 37482    cjadeau@ch-lemans.fr   
Contact: Hikombo HITOTO    0243434343    hhitoto@ch-lemans.fr   
Sponsors and Collaborators
Centre Hospitalier le Mans
More Information
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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT04561154    
Other Study ID Numbers: CHM-2020/S10/04
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier le Mans:
SARS-COV2
functionnal complaints
sequel
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases