Evaluation of the Impact of Hospitalization in Intensive... | NCT04849585

Studies
Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection

NCT04849585

Sponsor

Tourcoing Hospital

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Covid19

Interventions

semi-directed entretien

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

May 2022

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

Jun 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Feb 23, 2021

First Submission Date that Met QC Criteria

Apr 14, 2021

First Posted Date

Apr 19, 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

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

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

To evaluate the psychological, physical, social, professional and family impact of a hospitalization in intensive care for a covid 19 by analysis of the verbatim during a semi-structured interview.

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

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
semi-directed entretien	Other	semi-directed entretien

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychological impact of hospitalization in intensive care for a covid 19.	Frequency of recurring nightmares, irritability and anxious patient	At day 1
Physical impact of hospitalization in intensive care for a covid 19.	Frequency of Handicap and resumption of professional and personal activities	At day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients hospitalized in intensive care at CH Dron for a COVID 19 who have given their agreement during their follow-up consultation

Exclusion Criteria:

Minor patient
Patient does not speak French
Refusal to participate

Accepts Healthy Volunteers

Not provided

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

Patients hospitalized in intensive care at CH Dron for a COVID 19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pauline THILL, MD	Contact	0320694949		pthill@ch-tourcoing.fr
Solange TREHOUX, PhD	Contact	0320694280		strehoux@ch-tourcoing.fr

Overall Officials

Name	Affiliation	Role
Pauline THILL, MD	CH TOURCOING	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CH Tourcoing		Tourcoing			France	Pauline THILL

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