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Clinical Trials/NCT05731583
NCT05731583
Recruiting
Not Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country300 target enrollmentJanuary 6, 2021
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
300
Locations
1
Primary Endpoint
Number of patients without missing days of telemonitoring/total patients
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 6, 2021
End Date
January 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

RICHELDI LUCA

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of patients without missing days of telemonitoring/total patients

Time Frame: 14 days

Number of patients without missing days of telemonitoring/total patients

Secondary Outcomes

  • Number of subject hospitalized/total patients(3 yars)
  • Oxygen saturation measurements(14 days)
  • Cost efficacy(14 days)
  • Descriptive statistics(14 days)
  • Correlation between the number of comorbidities and smoking status and SpO2 nadir(14 days)

Study Sites (1)

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