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临床试验/NCT04898179
NCT04898179已完成不适用

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]

Istituti Clinici Scientifici Maugeri SpA3 个研究点 分布在 1 个国家目标入组 796 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
796
试验地点
3
主要终点
Number of Re-hospitalisation at three months

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalisation for COVID19
  • Patients discharged at home

排除标准

  • Patient refusal
  • Patients discharged at a nursing home

结局指标

主要结局

Number of Re-hospitalisation at three months

时间窗: 3 months

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

ER access at three months

时间窗: 3 months

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

Death at three months

时间窗: 3 months

Number of death at three months in two groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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