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

NCT05731583 | Unknown

• 1 other identifier: 4985
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of patients without missing days of telemonitoring/total patients

  Number of patients without missing days of telemonitoring/total patients

  14 days

Secondary Outcomes (5)

• Oxygen saturation measurements

  14 days

• Number of subject hospitalized/total patients

  3 yars

• Descriptive statistics

  14 days

• Correlation between the number of comorbidities and smoking status and SpO2 nadir

  14 days

• Cost efficacy

  14 days

Study Arms (2)

Recovering COVID

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

Ongoing COVID

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

Device: Home pulse oximetry monitoring

Interventions

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.

Ongoing COVID; Recovering COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients of any gender, with confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Luca Richeldi, MD

CONTACT

+390630157852; luca.richeldi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 16, 2023
• Study Start: January 6, 2021
• Primary Completion: July 30, 2021
• Study Completion: January 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)