Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19

Recruiting

• Conditions: COVID-19
• Interventions: Device: Home pulse oximetry monitoring

• Registration Number: NCT05731583
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The COVID-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. The Gemelli Polyclinic in Rome provided a digital health program (SATCOV) to monitor at home newly diagnosed COVID-19 patient, or after an early discharge from the COVID units.

A digital application and a wireless oximeter were provided to patients. Oxygen saturation, heart rate and body temperature were monitored. The aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in COVID-19 patients.

Clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated COVID unit if necessary.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-06
• Primary Completion: 2021-07-30
• Status Verified: 2023-02
• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• adult patients (age>18)
• confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)
• clinical condition compatible with hospital discharge (for recoving COVID group) or home management (for ongoing COVID group)

Exclusion Criteria

• non-autonomous patients
• patients without a smartphone and home internet connection
• patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation
• the presence of severe comorbidities that could compromise the safety of telemonitoring

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recovering COVID	Home pulse oximetry monitoring	Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring.
Ongoing COVID	Home pulse oximetry monitoring	Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization.

Primary Outcome Measures

Name	Time	Method
Number of patients without missing days of telemonitoring/total patients	14 days	Number of patients without missing days of telemonitoring/total patients

Secondary Outcome Measures

Name	Time	Method
Number of subject hospitalized/total patients	3 yars	Number of subject hospitalized/total patients
Oxygen saturation measurements	14 days	Number of oxygen saturation measurements performed/total measurements required by protocol
Cost efficacy	14 days	Calculation of resources spent per patient
Descriptive statistics	14 days	Groups' description of their clinical and demographics characteristics
Correlation between the number of comorbidities and smoking status and SpO2 nadir	14 days	Correlation between the number of comorbidities and smoking status and SpO2 nadir

Trial Locations

Locations (1)

Fondazione Policlinico Agostino Gemelli IRCCS; 🇮🇹 Rome, Roma, Italy