Support for COVID19 Patients at Home (Mirato)

September 27, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

796

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Istituto Auxologico Italiano
    • Bergamo
      • Seriate, Bergamo, Italy
        • Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • ICS Maugeri
    • Varese
      • Tradate, Varese, Italy
        • ICS Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients hospitalized for COVID19

Description

Inclusion Criteria:

  • Hospitalisation for COVID19
  • Patients discharged at home

Exclusion Criteria:

  • Patient refusal
  • Patients discharged at a nursing home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Telecare group

When 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.
Other: Telecare Group

Home-based telehealth program: telenursing and specialist teleconsultation

Telemonitoring with a new pulse oximeter and specific App

E-health platform

Videoconference
Control group
The 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.
Other: Control group
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Re-hospitalisation at three months
Time Frame: 3 months
Number of Re-hospitalisation registered at three months period in two groups
3 months
ER access at three months
Time Frame: 3 months
Number of ER accesses registered at three months period in two groups
3 months
Death at three months
Time Frame: 3 months
Number of death at three months in two groups
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Istituto Auxologico Italiano
Azienda Ospedaliera Bolognini di Seriate Bergamo
Azienda Socio Sanitaria Territoriale di Bergamo
University of Bergamo

Investigators

  • Study Chair: Simonetta Scalvini, MD, Istituti Clinici Scientifici Maugeri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 16, 2022

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICS Maugeri CE2455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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