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

Completed

• Conditions: Quality of Life
• Interventions: Behavioral: administration of questionnaires

• Registration Number: NCT05408286
• Lead Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

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.

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2022-03-04
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-06
• Last Update Submitted: 2022-06-06
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
inclusion criteria	administration of questionnaires	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.

Primary Outcome Measures

Name	Time	Method
COVID-19 qualità di vita	8 mesi	polmonite COVID-19 qualità di vita

Trial Locations

Locations (1)

Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy