AzTrials
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COVID19 PatientsMiratoNCT04898179

Support for COVID19 Patients at Home

An observational study of COVID19 Patients, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID19 Patients
What is being tested?
Telecare Group
How many people
796 participants
Where
4 sitesItaly
Study dates
1 Nov 2020to 16 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients hospitalized for COVID19

Who may be able to join

  • Hospitalisation for COVID19
  • Patients discharged at home

Who cannot join

  • Patient refusal
  • Patients discharged at a nursing home

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Ics Maugeri

    Lumezzane, Brescia, 25065

  • Istituto Auxologico Italiano

    Milan

  • Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate

    Seriate, Bergamo

  • Ics Maugeri

    Tradate, Varese

Other trials in Italy

About this study

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]

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.

Read the 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
Being tested
Telecare Group, Control group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telecare GroupOther

    Home-based telehealth program: telenursing and specialist teleconsultation

    Telemonitoring with a new pulse oximeter and specific App

    E-health platform

    Videoconference

  • Control groupOther

    Usual care

Study groups in NCT04898179
Study groupRoleWhat they receive
Telecare groupWhen discharged, patients will be followed at home by a telecare nursing and specialist teleconsultation program for 3 months. The key element of the program will be a structured nurse-managed telephone support and, when necessary, video consultations, to follow patients, for the first month. During these contacts, the nurse will conduct a standardized interview enquiring about the general clinical condition of the patient. In the case of any symptom or problem, the patient will be able to call the service. At the end of the third month, patients will contact again to check their clinical condition and to close the program. Patients will be provided with a pulse oximeter to measure O2 saturation. At the start and end of the program, patients were administered the SF-12 quality of life questionnaire.
Receives: Other: Telecare Group
Control groupThe patients in the control group will be followed by their general practitioner and they will be contacted after three months to check their clinical condition.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Re-hospitalisation at three months

    Number of Re-hospitalisation registered at three months period in two groups

    Measured: 3 months

  2. ER access at three months

    Number of ER accesses registered at three months period in two groups

    Measured: 3 months

  3. Death at three months

    Number of death at three months in two groups

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2021
  2. Study start1 Nov 2020
  3. Primary completion31 Dec 2021
  4. Study completion16 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
796 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04898179
Sponsor's protocol ID
ICS Maugeri CE2455
Acronym
Mirato
Status last verified
Sep 2023
First submitted
21 May 2021
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Word Health Organization. WHO Coronavirus Disease (COVID-19) Dashboard. Available at https://covid19.who.int 2020. (last accessed March 2021).

  • 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.

    PubMed 32746750

  • 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.

    PubMed 32379036

  • 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.

    PubMed 33232204

  • 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.

    PubMed 28537509

  • 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.

    PubMed 36206021

  • 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.

    PubMed 37645519

  • 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.

    PubMed 37588158

Questions about this trial

What is this clinical trial studying?

An observational study of COVID19 Patients, run by Istituti Clinici Scientifici Maugeri SpA at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Re-hospitalisation at three months (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04898179, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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