Emergency Department (ED) Self-Monitoring Pilot COVID-19
Primary Purpose
COVID, Covid-19, SARS-CoV 2
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Symptoms entered into the CovidX application
Sponsored by
About this trial
This is an interventional other trial for COVID focused on measuring coronavirus
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient's symptom data without pulse oximeter
Patient's symptom data with a pulse oximeter
Arm Description
Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation 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.
Outcomes
Primary Outcome Measures
Change in the percent of participants using the CovidX web application (app) on 50% or greater of days
Average compliance rate with daily symptom tracking by day 30
Recruitment rate
The proportion of patients approached for the study who enroll
Secondary Outcome Measures
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.
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.
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.
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
Full Information
NCT ID
NCT04462783
First Posted
July 7, 2020
Last Updated
June 28, 2021
Sponsor
University of Michigan
Collaborators
Vironix Health Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT04462783
Brief Title
Emergency Department (ED) Self-Monitoring Pilot COVID-19
Official Title
Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Not funded
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Vironix Health Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Covid-19, SARS-CoV 2
Keywords
coronavirus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Some patients will have pulse oximeters or be given one and provide data from these.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient's symptom data without pulse oximeter
Arm Type
Experimental
Arm Description
Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.
Arm Title
Patient's symptom data with a pulse oximeter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Symptoms entered into the CovidX application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the percent of participants using the CovidX web application (app) on 50% or greater of days
Time Frame
baseline, up to 30 days
Title
Average compliance rate with daily symptom tracking by day 30
Time Frame
Day 30
Title
Recruitment rate
Description
The proportion of patients approached for the study who enroll
Time Frame
through study completion an average of 1 year
Secondary Outcome Measure Information:
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a
Description
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.
Time Frame
completed at baseline (enrollment), up to 30 days
Title
Change in Coronavirus Anxiety Scale
Description
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.
Time Frame
completed at baseline (enrollment), up to 30 days
Title
CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire
Description
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.
Time Frame
30 days
Title
Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter
Description
This will be measured by the compliance rates
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Li, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Emergency Department (ED) Self-Monitoring Pilot COVID-19
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