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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Withdrawn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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID focused on measuring coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 7, 2020
    Last Updated
    June 28, 2021
    Sponsor
    University of Michigan
    Collaborators
    Vironix Health Incorporated
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    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

    We'll reach out to this number within 24 hrs