Clinical trial NCT04898179: Support for COVID19 Patients at Home
Official title: Targed Support for Patients Discharged After Hospitalization for SARS-CoV-2 Infection and Comorbidities. [ITALIAN. Supporto MIRATO ai Pazienti Dimessi Dopo un Ricovero Per Infezione da SARS-CoV-2 e comorbidità]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19 Patients
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: Azienda Ospedaliera Bolognini di Seriate Bergamo
name: Azienda Socio Sanitaria Territoriale di Bergamo
name: University of Bergamo
First posted: 2021-05-24
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients hospitalized for COVID19

Brief summary: The rapid spread and increase of acute respiratory infection cases caused by the novel SARS-CoV-2 coronavirus represent a major challenge for healthcare systems around the world. The shortage of facilities and medical personnel is a major problem in the face of a serious epidemic. The Lombardy Region, and in particular the territories of Milan, Bergamo and Brescia, was the most affected due to the rapid increase in cases and limited medical resources during the initial phase of the epidemic.

The collaboration between hospital and territory with integrated communication systems and the monitoring of patients with appropriate technological tools that include telemedicine, are fundamental to ensure the continuity of care and the sustainability of the health system, also significantly reducing the risk of contagion for health professionals.

Detailed description: The MIRATO Project wants to test the remote health surveillance services and a telemonitoring program for patients discharged after a period of hospitalization for COVID19 caused by the new coronavirus SARS-CoV-2 and their comorbidities if present.

Patients discharged from hospitals still present in many cases breathing difficulties, bed rest symptoms and other disabilities related to the acute event. In addition, some patients are seeing rekindling of symptoms such as fever, dry cough, difficulty respiratory and blood desaturation into oxygen. These problems underline the need for procedures that allow us to safely discharge patients to be able to better follow their convalescence but also to be able to intervene quickly in the event of symptoms returning.

The purpose of the home health surveillance intervention will be:

* Monitor the evolution of the state of health with standardized tools based on scientific evidence
* Provide counselling support to help recovery
* Have certain and early identification of signs and symptoms related to a possible resumption of the COVID19 pathology and or to comorbidities
* Compare outcome results with case-control design three months after hospital discharge

Eligibility criteria: Inclusion Criteria:

* Hospitalisation for COVID19
* Patients discharged at home

Exclusion Criteria:

* Patient refusal
* Patients discharged at a nursing home

Primary outcomes:
measure: Number of Re-hospitalisation at three months
timeFrame: 3 months
measure: ER access at three months
timeFrame: 3 months
measure: Death at three months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seriate
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate
state: Bergamo
city: Lumezzane
country: Italy
facility: Ics Maugeri
state: Brescia
city: Tradate
country: Italy
facility: Ics Maugeri
state: Varese
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Simonetta Scalvini, MD
role: STUDY_CHAIR
References:
citation: Word Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available at https://covid19.who.int 2020. (last accessed March 2021).
citation: Tebeje TH, Klein J. Applications of e-Health to Support Person-Centered Health Care at the Time of COVID-19 Pandemic. Telemed J E Health. 2021 Feb;27(2):150-158. doi: 10.1089/tmj.2020.0201. Epub 2020 Jul 31.
citation: Doshi A, Platt Y, Dressen JR, Mathews BK, Siy JC. Keep Calm and Log On: Telemedicine for COVID-19 Pandemic Response. J Hosp Med. 2020 May;15(5):302-304. doi: 10.12788/jhm.3419. Epub 2020 Apr 1. No abstract available.
citation: Tabacof L, Kellner C, Breyman E, Dewil S, Braren S, Nasr L, Tosto J, Cortes M, Putrino D. Remote Patient Monitoring for Home Management of Coronavirus Disease 2019 in New York: A Cross-Sectional Observational Study. Telemed J E Health. 2021 Jun;27(6):641-648. doi: 10.1089/tmj.2020.0339. Epub 2020 Oct 13.
citation: Scalvini S, Bernocchi P, Zanelli E, Comini L, Vitacca M; Maugeri Centre for Telehealth and Telecare (MCTT). Maugeri Centre for Telehealth and Telecare: A real-life integrated experience in chronic patients. J Telemed Telecare. 2018 Aug;24(7):500-507. doi: 10.1177/1357633X17710827. Epub 2017 May 24.
citation: Vitali A, Ghidotti A, Savoldelli A, Bonometti F, Rizzi C, Bernocchi P, Borghi G, Scalvini S. Definition of a Method for the Evaluation of Telemedicine Platforms in the Italian Context. Telemed J E Health. 2023 May;29(5):769-777. doi: 10.1089/tmj.2022.0326. Epub 2022 Oct 7.
citation: Bernocchi P, Crotti G, Beato E, Bonometti F, Giudici V, Bertolaia P, Perger E, Remuzzi A, Bachetti T, La Rovere MT, Dalla Vecchia LA, Angeli F, Parati G, Borghi G, Vitacca M, Scalvini S. COVID-19 teleassistance and teleconsultation: a matched case-control study (MIRATO project, Lombardy, Italy). Front Cardiovasc Med. 2023 Aug 14;10:1062232. doi: 10.3389/fcvm.2023.1062232. eCollection 2023.
citation: Bonometti F, Bernocchi P, Vitali A, Savoldelli A, Rizzi C, Scalvini S. Usability of a continuous oxygen saturation device for home telemonitoring. Digit Health. 2023 Aug 14;9:20552076231194547. doi: 10.1177/20552076231194547. eCollection 2023 Jan-Dec.