Support for COVID19 Patients at Home

Completed

• Conditions: COVID19 Patients
• Interventions: Other: Telecare Group; Other: Control group

• Registration Number: NCT04898179
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-16
• Status Verified: 2023-09
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

Inclusion Criteria

• Hospitalisation for COVID19
• Patients discharged at home

Exclusion Criteria

• Patient refusal
• Patients discharged at a nursing home

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Telecare group	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Number of Re-hospitalisation at three months	3 months	Number of Re-hospitalisation registered at three months period in two groups
ER access at three months	3 months	Number of ER accesses registered at three months period in two groups
Death at three months	3 months	Number of death at three months in two groups

Trial Locations

Locations (3)

Istituto Auxologico Italiano; 🇮🇹 Milano, Italy

Azienda Socio Sanitaria Territoriale (ASST) BERGAMO EST, Ospedale Bolognini di Seriate; 🇮🇹 Seriate, Bergamo, Italy

Ics Maugeri; 🇮🇹 Tradate, Varese, Italy