COVIDNCT04462783
Emergency Department (ED) Self-Monitoring Pilot COVID-19
A study testing Symptoms entered into the CovidX application in people with COVID and Covid-19, run by University of Michigan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Covid-19, SARS-CoV 2
- What is being tested?
- Symptoms entered into the CovidX application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reported symptoms of viral illness during ED encounter
- Tested for SARS-CoV-2 (COVID-19) during ED encounter
- Discharged home from the Emergency Department
Who cannot join
- Prisoners
- Residents of congregate living facilities who are already being monitored
- Baseline oxygen requirement
- Patients whose primary goals of care are palliative
- Pregnant women
About this study
Official title: Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge
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.
- Conditions
- COVID, Covid-19, SARS-CoV 2
- Being tested
- Symptoms entered into the CovidX application
- Keywords
- coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptoms entered into the CovidX applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient's symptom data without pulse oximeter | Experimental | Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application. Receives: Other: Symptoms entered into the CovidX application |
| Patient's symptom data with a pulse oximeter | Experimental | 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. Receives: Other: Symptoms entered into the CovidX application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percent of participants using the CovidX web application (app) on 50% or greater of days
Measured: baseline, up to 30 days
Average compliance rate with daily symptom tracking by day 30
Measured: Day 30
Recruitment rate
The proportion of patients approached for the study who enroll
Measured: through study completion an average of 1 year
Secondary outcomes (4)
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.
Measured: completed at baseline (enrollment), up to 30 days
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.
Measured: completed at baseline (enrollment), up to 30 days
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.
Measured: 30 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study startJun 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Some patients will have pulse oximeters or be given one and provide data from these.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Vironix Health Incorporated
- Responsible party
- Principal investigator, Kathleen Li, University of Michigan
- Investigators
- Kathleen Li, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462783
- Sponsor's protocol ID
- HUM00181946
- Status last verified
- Jun 2021
- First submitted
- 7 Jul 2020
- Last updated
- 1 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge
- ClinicalTrials.gov ID
- NCT04462783
- Acronym / sponsor ID
- HUM00181946
- Conditions
- COVID, Covid-19, SARS-CoV 2
- Keywords
- coronavirus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Vironix Health Incorporated
- Study start
- Jun 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Some patients will have pulse oximeters or be given one and provide data from these.
| Arm | Type | Receives |
|---|---|---|
| Patient's symptom data without pulse oximeter | Experimental | Other: Symptoms entered into the CovidX applicationSome patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application. |
| Patient's symptom data with a pulse oximeter | Experimental | Other: Symptoms entered into the CovidX applicationSome patients will be given (or may have) a pulse oximeter in order to enter heart rate and O2 saturation data into the CovidX application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Reported symptoms of viral illness during ED encounter
- Tested for SARS-CoV-2 (COVID-19) during ED encounter
- Discharged home from the Emergency Department
Key exclusion criteria (5 listed)
- Prisoners
- Residents of congregate living facilities who are already being monitored
- Baseline oxygen requirement
- Patients whose primary goals of care are palliative
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptoms entered into the CovidX applicationParticipants 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. | Other | Patient's symptom data with a pulse oximeter, Patient's symptom data without pulse oximeter |
Primary outcome
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
Average compliance rate with daily symptom tracking by day 30
Time frame: Day 30
Recruitment rate
Time frame: through study completion an average of 1 year
The proportion of patients approached for the study who enroll
4 secondary outcomes
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a
Time frame: completed at baseline (enrollment), up to 30 days
Change in Coronavirus Anxiety Scale
Time frame: completed at baseline (enrollment), up to 30 days
CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire
Time frame: 30 days
Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Li, MD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Symptoms entered into the CovidX application in people with COVID and Covid-19, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.