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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Device: Home pulse oximetry monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recovering COVID<br>Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring. | Device: Home pulse oximetry monitoring<br>* A digital application and a wireless oximeter were provided to both groups. Oxygen saturation, heart rate and (optional) body temperature were monitored at least twice a day.<br>|
| Ongoing COVID<br>Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization. | Device: Home pulse oximetry monitoring<br>* A digital application and a wireless oximeter were provided to both groups. Oxygen saturation, heart rate and (optional) body temperature were monitored at least twice a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without missing days of telemonitoring/total patients | Number of patients without missing days of telemonitoring/total patients | 14 days | 

Secondary Outcome Measures

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