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

Not Applicable

Withdrawn

• Conditions: Covid-19; COVID; SARS-CoV 2
• Interventions: Other: Symptoms entered into the CovidX application

• Registration Number: NCT04462783
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Status Verified: 2021-06
• Study Start: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-11
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient's symptom data with a pulse oximeter	Symptoms entered into the CovidX application	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.
Patient's symptom data without pulse oximeter	Symptoms entered into the CovidX application	Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a	completed at baseline (enrollment), up to 30 days	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.
Change in Coronavirus Anxiety Scale	completed at baseline (enrollment), up to 30 days	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.
CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire	30 days	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.
Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter	30 days	This will be measured by the compliance rates