COVID, Covid-19, SARS-CoV 2
Conditions
Keywords
coronavirus
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.
Interventions
OTHERSymptoms 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.
Sponsors
Vironix Health Incorporated
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Some patients will have pulse oximeters or be given one and provide data from these.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through study completion an average of 1 year | The proportion of patients approached for the study who enroll |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Outcome results
None listed