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

Conditions

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

  • France
      • Dijon, France
        • Chu Dijon Bourogne

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.
Other: Questionnaires
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.

Sponsor

Centre Hospitalier Universitaire Dijon

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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