- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609839
FOLLOW-UP OF PATIENTS WITH COVID-19. (TeleRea'nCo)
TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Contacts and Locations
Study Locations
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-
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Strasbourg, France, 67091
- Hôpitaux Universitaires de Strasbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patient admitted to intensive care unit for COVID-19
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months
Time Frame: 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
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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
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2) Number of re-hospitalizations at 3, 6 and 12 months
Time Frame: 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
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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
Time Frame: Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
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Date of death will be collected from inclusion to M12 (12 months after patient inclusion)
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4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months
Time Frame: 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
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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
Time Frame: 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
|
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
|
|
5) Cost of health expenditure
Time Frame: The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
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The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeleRea'nCo
- 7883 (Other Identifier: Hôpitaux Universitaires de Strasborug)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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