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

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid-19, COVID, SARS-CoV 2

Intervention / Treatment
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* Other: Symptoms entered into the CovidX application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Some patients will have pulse oximeters or be given one and provide data from these.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient's symptom data without pulse oximeter<br>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<br>* 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.<br>|
| Experimental: Patient's symptom data with a pulse oximeter<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronavirus