Remote Monitoring of COVID-19 Positive Outpatients

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

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).

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Other: Remote Monitoring of COVID-19

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Clinic, Emory University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study population is obtained from patients admitted to the hospital or enrolled in the Emory COVID-19 Outpatient Remote Monitoring Registry (E-CORMR) by nursing triage for suspicion of COVID-19.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remote Monitoring of COVID-19; Patients with COVID-19 who completed acute clinical monitoring of at least 30 days from symptom onset or positive COVID-19 test.	Other: Remote Monitoring of COVID-19; Remote monitoring of acute COVID-19 illness included use of a Medtronic pulse oximeter, photoplethysmography (PPG), patient-reported symptoms data, static vital signs captured during the course of the clinical evaluation and various physiomarkers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify Parameters Associated with Adverse Outcomes	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.	Up to 2 months after creation of the registry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop Algorithm for Deterioration	The E-CORMR database will be used to develop a robust clinical algorithm for deterioration among patients with COVID-19.	Up to 2 months after creation of the registry

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Medtronic
• Investigators: Principal Investigator: Blake Anderson, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; Risk assessment
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: STUDY00001408

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