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

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: administration of questionnaires

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 Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; administration of questionnaires

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Investigators: Principal Investigator: Tatiana Bolgeo, PhD, Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VIDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No