FOLLOW-UP OF PATIENTS WITH COVID-19.

Patient Admitted to Intensive Care Unit for COVID-19 Clinical Trial

— TeleRea'nCo  

Official title:

TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609839
• Other study ID #: TeleRea'nCo
• Secondary ID: 7883
• Status: Recruiting
• Start date: October 27, 2020
• Est. completion date: April 27, 2023

Study information

• Verified date: October 2020
• Source: University Hospital, Strasbourg, France
• Contact: Eric DEMONSANT
• Phone: +33 3 88 11 54 15
• Email: eric.demonsant[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 27, 2023
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient Admitted to Intensive Care Unit for COVID-19

Intervention

Other:
• Follow-up of patients with COVID-19
The presence of sequelae, number of re-hospitalizations, date of death and cost of health expenditure will be collected. The Quality of life score (SF-36 questionnaire) and the Pittsburgh sleep quality index (PSQI questionnaire) will be completed by patients.

Locations

Country	Name	City	State
France	Hopitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
Secondary	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
Secondary	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
Secondary	3) Date of death		Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
Secondary	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
Secondary	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
Secondary	5) Cost of health expenditure		The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)