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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-06

Study Completion Date

2024-01-31

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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Recovering COVID

Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring.

Home pulse oximetry monitoring

Intervention Type 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.

Ongoing COVID

Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization.

Home pulse oximetry monitoring

Intervention Type 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.

Interventions

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Home pulse oximetry monitoring

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No