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临床试验/NCT04853108
NCT04853108终止不适用

Using Telemedicine, Remote Physiologic Monitoring, and Mobile Self-reported Symptom Surveys to Improve Care for COVID-19 Patients

Emory University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
300
试验地点
1
主要终点
Identify Parameters Associated with Adverse Outcomes

研究概览

简要总结

This study seeks to evaluate how secondary data retrieved from remote physiological monitoring performed during routine outpatient/at-home care periods can allow for the discovery of novel physiomarkers that predict acute deterioration or hospitalization among people testing positive for Coronavirus Disease 2019 (COVID-19).

详细描述

Most recent research publications and clinical trials have exclusively focused on the hospital and intensive care unit (ICU) care of COVID-19 patients. Few have focused on how to direct care delivered at home, where the majority of coronavirus infected will recover, and how and when to rescue those who are at immediate risk for poor outcomes. To standardize the home monitoring process and offer guidance in this uncharted territory, the researchers have created a method for outpatient management of COVID-19 patients and high suspicion influenza-like illness (ILI) for Emory University Hospital. This includes the newly implemented model of clinics including in-person ambulatory management in the Acute Respiratory Clinic (ARC), the Virtual Outpatient Management Clinic (VOMC), and the Emory COVID-19 Outpatient Remote Monitoring Registry (E-CORMR). Initial analysis of the management system, particularly in risk tier assignment, has shown that assigning risk tiers early can help to identify patients at risk for clinical deterioration. The researchers have also demonstrated symptom profiles and durations of the "typical" outpatient disease course. The E-CORMR was used to create a dashboard for improved management of these frequently complex patients. It was determined after its creation that it could also be used for research purposes to store data collected from physiologic parameters.

The goal of this study is to develop algorithms using secondary data abstracted from remote monitoring devices that were collected within the E-CORMR. The researchers propose to derive robust algorithms through the analysis of that data that identify a potential hospitalization. The findings will not only improve the management of patients with known or suspected COVID-19 but also provide information that allows early intervention on patients at risk of decompensation. This information can then be used by other healthcare systems to care for patients more safely at home, thus reducing the impact of COVID-19 on overburdened acute care settings and preventing poor outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • identified to be positive for COVID-19 by Quantitative Reverse Transcription polymerase chain reaction (qRT-PCR)
  • demonstrate symptoms of COVID-19
  • symptom onset within 7 days
  • completed 21 days of remote monitoring with a Medtronic remote pulse oximeter device

排除标准

  • 未提供

结局指标

主要结局

Identify Parameters Associated with Adverse Outcomes

时间窗: Up to 2 months after creation of the registry

The Emory COVID-19 outpatient remote monitoring registry (E-CORMR) will be used to identify physiologic parameters and symptom responses that are associated with adverse outcomes.

次要结局

  • Develop Algorithm for Deterioration(Up to 2 months after creation of the registry)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Blake Anderson

Assistant Professor

Emory University

研究点 (1)

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