Perceived Health After Hospitalization for COVID-19 | NCT04912804

Studies
Perceived Health After Hospitalization for COVID-19

NCT04912804

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Apr 15, 2022Actual

Enrollment

207Actual

Phase

Not provided

Conditions

COVID-19, Post-hospitalization, Disease Impact

Interventions

Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2020Actual

Primary Completion Date

May 22, 2021Actual

Completion Date

May 22, 2021Actual

First Submitted Date

Jun 2, 2021

First Submission Date that Met QC Criteria

Jun 2, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2022

Last Update Posted Date

Apr 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 Patient		Patient discharged from a conventional short-stay hospitalization unit.	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other	SF-12, GHQ-12 and HAQ	COVID-19 Patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided