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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04462783
• Other study ID #: HUM00181946
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: November 2021

Study information

• Verified date: June 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Covid-19
• Emergencies
• SARS-CoV 2

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Vironix Health Incorporated

Outcome

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