Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898179
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2021-05-21
Brief Title:
Support for COVID19 Patients at Home
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mirato
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None