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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recovering COVID | Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring. |
| |
| Ongoing COVID | Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home pulse oximetry monitoring | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients of any gender, with confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Richeldi, MD | Contact | +390630157852 | luca.richeldi@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Agostino Gemelli IRCCS | Recruiting | Rome | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |