Emergency Department (ED) Self-Monitoring Pilot COVID-19

Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge

This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one).

The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.

Study Overview

• Status: Withdrawn
• Conditions: Covid-19; SARS-CoV 2; COVID
• Intervention / Treatment: Other: Symptoms entered into the CovidX application

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Reported symptoms of viral illness during ED encounter
• Tested for SARS-CoV-2 (COVID-19) during ED encounter
• Discharged home from the Emergency Department

Exclusion Criteria:

• Prisoners
• Residents of congregate living facilities who are already being monitored
• Baseline oxygen requirement
• Patients whose primary goals of care are palliative
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient's symptom data without pulse oximeter; Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.	Other: Symptoms entered into the CovidX application; Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.
Experimental: Patient's symptom data with a pulse oximeter; Some patients will be given (or may have) a pulse oximeter in order to enter heart rate and O2 saturation data into the CovidX application.	Other: Symptoms entered into the CovidX application; Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the percent of participants using the CovidX web application (app) on 50% or greater of days		baseline, up to 30 days
Average compliance rate with daily symptom tracking by day 30		Day 30
Recruitment rate	The proportion of patients approached for the study who enroll	through study completion an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a	The PROMIS Emotional Distress-Anxiety-Short Form 4a is a 4-item scale that assesses fear, anxiety, worry, and uneasiness. It uses a 5-point Likert scale (1 = never to 5 = always). Raw scores range from 4-20 with lower scores representing less endorsement of anxiety.	completed at baseline (enrollment), up to 30 days
Change in Coronavirus Anxiety Scale	This is a 5- item questionnaire that assess anxiety related to the Coronavirus. Participants select from (0 = not at all to 4 = nearly every day over the last 2 weeks). The higher the total number the more anxiety.	completed at baseline (enrollment), up to 30 days
CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire	The questionnaire is a series of 8 questions answered on a 1-7 Likert scale, with lower numbers indicating better usability. There are also 2 open-ended questions about why participants did or didn't like the application and other feedback is collected.	30 days
Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter	This will be measured by the compliance rates	30 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Vironix Health Incorporated
• Investigators: Principal Investigator: Kathleen Li, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: coronavirus
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies
• Other Study ID Numbers: HUM00181946

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No