<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04462783</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00181946</org_study_id>
    <nct_id>NCT04462783</nct_id>
  </id_info>
  <brief_title>Emergency Department (ED) Self-Monitoring Pilot COVID-19</brief_title>
  <official_title>Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vironix Health Incorporated</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This feasibility study is being conducted to understand how discharged emergency department&#xD;
      patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking&#xD;
      web application. Study participants that are enrolled in the study will be asked to enter&#xD;
      daily information about their health into the CovidX web application (app.). In addition,&#xD;
      patients will answer questions regarding anxiety levels, use a pulse oximeter to record&#xD;
      information (if you own one or are given one).&#xD;
&#xD;
      The investigators predict that participants will be able to engage with the CovidX web&#xD;
      application over several days to weeks for the purposes of symptom tracking, and may have&#xD;
      decreased anxiety over the study period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not funded&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Some patients will have pulse oximeters or be given one and provide data from these.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the percent of participants using the CovidX web application (app) on 50% or greater of days</measure>
    <time_frame>baseline, up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average compliance rate with daily symptom tracking by day 30</measure>
    <time_frame>Day 30</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>through study completion an average of 1 year</time_frame>
    <description>The proportion of patients approached for the study who enroll</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a</measure>
    <time_frame>completed at baseline (enrollment), up to 30 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Coronavirus Anxiety Scale</measure>
    <time_frame>completed at baseline (enrollment), up to 30 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire</measure>
    <time_frame>30 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter</measure>
    <time_frame>30 days</time_frame>
    <description>This will be measured by the compliance rates</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>Covid-19</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Patient's symptom data without pulse oximeter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient's symptom data with a pulse oximeter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptoms entered into the CovidX application</intervention_name>
    <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.</description>
    <arm_group_label>Patient's symptom data with a pulse oximeter</arm_group_label>
    <arm_group_label>Patient's symptom data without pulse oximeter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reported symptoms of viral illness during ED encounter&#xD;
&#xD;
          -  Tested for SARS-CoV-2 (COVID-19) during ED encounter&#xD;
&#xD;
          -  Discharged home from the Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Residents of congregate living facilities who are already being monitored&#xD;
&#xD;
          -  Baseline oxygen requirement&#xD;
&#xD;
          -  Patients whose primary goals of care are palliative&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Kathleen Li</investigator_full_name>
    <investigator_title>Adjunct Clinical Lecturer in Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04462783
org study id: HUM00181946
nct id: NCT04462783
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Other
masking: None (Open Label)
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
measure: Average compliance rate with daily symptom tracking by day 30
time frame: Day 30
measure: Recruitment rate
time frame: through study completion an average of 1 year
description: The proportion of patients approached for the study who enroll
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a
time frame: completed at baseline (enrollment), up to 30 days
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.
measure: Change in Coronavirus Anxiety Scale
time frame: completed at baseline (enrollment), up to 30 days
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.
measure: CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire
time frame: 30 days
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.
measure: Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter
time frame: 30 days
description: This will be measured by the compliance rates
arm group label: Patient's symptom data without pulse oximeter
arm group type: Experimental
description: Some patients may not be given a pulse oximeter to enter heart rate and O2 saturation into the CovidX application.
arm group label: Patient's symptom data with a pulse oximeter
arm group type: Experimental
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: Symptoms entered into the CovidX application
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.
arm group label: Patient's symptom data with a pulse oximeter
arm group label: Patient's symptom data without pulse oximeter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathleen Li, MD
role: Principal Investigator
affiliation: University of Michigan
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Kathleen Li
investigator title: Adjunct Clinical Lecturer in Emergency Medicine
mesh term: COVID-19
mesh term: Emergencies