- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04912804
Perceived Health After Hospitalization for COVID-19 (PRO-COVID)
April 14, 2022 updated by: Centre Hospitalier Universitaire Dijon
There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization.
For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score.
Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
207
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Dijon, France
- Chu Dijon Bourogne
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient with COVID-19 discharged from a conventional short-stay hospital ward.
Description
Inclusion Criteria:
- Adult patient
- Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan
- Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection
- Patient providing oral consent to participate in the study
- Patient able to understand and answer the questionnaires used
- Patient able to answer the questions on an electronic device and to receive requests by email and/or SMS
- Patient who has electronic equipment at home and an Internet subscription allowing him/her to answer the questionnaires online
Exclusion Criteria:
- Patient under guardianship, curatorship or a measure of judicial safeguard
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
COVID-19 Patient
Patient discharged from a conventional short-stay hospitalization unit.
|
SF-12, GHQ-12 and HAQ
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
The value of perceived health scores in patients who achieved PASS and MCII
Time Frame: Through study completion, an average of 6 months
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2020
Primary Completion (Actual)
May 22, 2021
Study Completion (Actual)
May 22, 2021
Study Registration Dates
First Submitted
June 2, 2021
First Submitted That Met QC Criteria
June 2, 2021
First Posted (Actual)
June 3, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEVILLIERS AOIc 2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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