Influence of the COvid-19 Epidemic on STRESS | NCT04308187

Studies
Influence of the COvid-19 Epidemic on STRESS

NCT04308187

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Mar 13, 2020Actual

Enrollment

50,000Estimated

Phase

Not provided

Conditions

Stress, Psychological

Interventions

Not provided

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2020Estimated

Primary Completion Date

Mar 2022Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Mar 12, 2020

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 13, 2020Actual

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

Mar 12, 2020

Last Update Posted Date

Mar 13, 2020Actual

Name	Class
UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France	UNKNOWN
Wittyfit, Paris, France	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Detailed Description

This is an observational study using a REDCap® questionnaire via an internet link, which will be distributed by any means (Facebook, Twitter, institution mailing lists via a referent, flash codes distributed to patients and the public, etc.).

The self-questionnaire will assess stress, perception and knowledge of the epidemic, the feeling of information on the part of businesses / establishments / governments, the means of protection used the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress	Stress level will be assessed by questionnaire	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Perception and knowledge of the epidemic	Perception and knowledge of the epidemic will be assessed by questionnaire	Day 1
Feeling of information on the part of companies / establishments / governments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Anyone volunteer to participate

Exclusion Criteria:

Anyone non-voluntary to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

General population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise Laclautre	Contact	0473754963		promo_interne_drci@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Fréderic DUTHEIL	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Clermont-Ferrand		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological
D018352	Coronavirus Infections

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D003333	Coronaviridae Infections
D030341	Nidovirales Infections

Browse Leaves

Not provided

Browse Branches

Not provided