NCT04609839
Withdrawn
Not Applicable
TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
University Hospital, Strasbourg, France1 site in 1 country200 target enrollmentSeptember 15, 2020
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient Admitted to Intensive Care Unit for COVID-19
- Sponsor
- University Hospital, Strasbourg, France
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
- Status
- Withdrawn
- Last Updated
- 7 months ago
Overview
Brief Summary
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.
The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient admitted to intensive care unit for COVID-19
- •Adult patient ≥ 18 years old
- •Subject having expressed his non-opposition to the research
- •Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme
Exclusion Criteria
- •Subject under safeguard of justice
- •Patient under guardianship or curatorship
Outcomes
Primary Outcomes
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
Time Frame: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
Secondary Outcomes
- 4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 3) Date of death(Date of death will be collected from inclusion to M12 (12 months after patient inclusion))
- 5) Cost of health expenditure(The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion))
- 1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 2) Number of re-hospitalizations at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
Study Sites (1)
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