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

• Sponsor: University of Michigan (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04462783
• Collaborator: Vironix Health Incorporated (Other)
• Enrollment: 0
• Arms: 2
• Anticipated Duration (Months): 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID; Covid-19; SARS-CoV 2	Other: Symptoms entered into the CovidX application	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Some patients will have pulse oximeters or be given one and provide data from these.Some patients will have pulse oximeters or be given one and provide data from these.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in the percent of participants using the CovidX web application (app) on 50% or greater of days [baseline, up to 30 days]

2. Average compliance rate with daily symptom tracking by day 30 [Day 30]

3. Recruitment rate [through study completion an average of 1 year]

   The proportion of patients approached for the study who enroll

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Michigan
• Vironix Health Incorporated

Investigators

• Principal Investigator: Kathleen Li, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Li, Adjunct Clinical Lecturer in Emergency Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT04462783
• Other Study ID Numbers: HUM00181946
• First Posted: Jul 8, 2020
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kathleen Li, Adjunct Clinical Lecturer in Emergency Medicine, University of Michigan: coronavirus
• Additional relevant MeSH terms: COVID-19; Emergencies

Study Results

No Results Posted as of Jul 1, 2021