Remote Monitoring of COVID-19 Positive Outpatients

• ClinicalTrials.gov Identifier: NCT04853108
• Recruitment Status: Enrolling by invitation
• First Posted: April 21, 2021
• Last Update Posted: February 10, 2022
• Sponsor: Emory University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Blake Anderson, Emory University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment
Covid19	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 Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Using Telemedicine, Remote Physiologic Monitoring, and Mobile Self-reported Symptom Surveys to Improve Care for COVID-19 Patients
• Actual Study Start Date: June 25, 2021
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Identify Parameters Associated with Adverse Outcomes [ Time Frame: 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Georgia

Emory Clinic, Emory University Hospital

Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Medtronic

Investigators

• Principal Investigator: Blake Anderson, MD; Emory University

More Information

• Responsible Party: Blake Anderson, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT04853108
• Other Study ID Numbers: STUDY00001408
• First Posted: April 21, 2021
• Last Update Posted: February 10, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Blake Anderson, Emory University:

Telemedicine; Risk assessment

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases