Post Covid-19 Quality of Life After Hospital Discharge in... | NCT05408286

Studies
Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP

NCT05408286

Sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Status

Completed

Last Update Posted

Jun 7, 2022Actual

Enrollment

145Actual

Phase

Not provided

Conditions

Quality of Life

Interventions

administration of questionnaires

Countries

Italy

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

Jun 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

Nov 1, 2020Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Jun 6, 2022

First Posted Date

Jun 7, 2022Actual

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

Jun 6, 2022

Last Update Posted Date

Jun 7, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bertolotti Marinella, biologa, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaOTHER

Collaborators

Not provided

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

A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

Detailed Description

The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia.

Enrollment took place only after the approval of the Ethics Committee of each participating center.

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

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
inclusion criteria		All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study.	Behavioral: administration of questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
administration of questionnaires	Behavioral	administration of questionnaires	inclusion criteria

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
COVID-19 qualità di vita	polmonite COVID-19 qualità di vita	8 mesi

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study

Exclusion Criteria:

Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tatiana Bolgeo, PhD	Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo		Alessandria		15121	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided