Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV
REPERCOV
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2020
CompletedFirst Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2022
CompletedMarch 9, 2022
March 1, 2022
1 year
September 9, 2020
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (12)
description of functionnal and psychosocial complaints
3 months after last hospitalization
description of functionnal and psychosocial complaints
3 months after last hospitalization
description of functionnal and psychosocial complaints
3 months after last hospitalization
description of functionnal and psychosocial complaints
3 months after last hospitalization
Identify the factors favoring the persistence of complaints
3 months after last hospitalization
- +7 more secondary outcomes
Study Arms (1)
patient hospitalized between march 1 and june 30, 2020
EXPERIMENTALpatient hospitalized between march 1 and june 30, 2020
Interventions
three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier du Mans
Le Mans, 72000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 23, 2020
Study Start
June 11, 2020
Primary Completion
June 11, 2021
Study Completion
June 11, 2022
Last Updated
March 9, 2022
Record last verified: 2022-03