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NCT05408286 Clinical Trial

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

Quality of Life Clinical Trial

— VIDI-CAP  

Official title:
Impact of COVID-19 on Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP: an Observational, Prospective Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05408286
Other study ID # VIDI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date June 30, 2021

Study information
Verified date June 2022
Source Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 95 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• administration of questionnaires
administration of questionnaires

Locations
Country Name City State
Italy Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo Alessandria

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 qualità di vita polmonite COVID-19 qualità di vita 8 mesi
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