NCT04912804

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

June 2, 2021

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease

    Through study completion, an average of 6 months

  • The value of perceived health scores in patients who achieved PASS and MCII

    Through study completion, an average of 6 months

Study Arms (1)

COVID-19 Patient

Patient discharged from a conventional short-stay hospitalization unit.

Other: Questionnaires

Interventions

SF-12, GHQ-12 and HAQ

COVID-19 Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with COVID-19 discharged from a conventional short-stay hospital ward.

You may qualify if:

  • 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

You may not qualify if:

  • Patient under guardianship, curatorship or a measure of judicial safeguard

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 3, 2021

Study Start

June 30, 2020

Primary Completion

May 22, 2021

Study Completion

May 22, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations