<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/NCT04420182</url>
  </required_header>
  <id_info>
    <org_study_id>CTO 3210</org_study_id>
    <nct_id>NCT04420182</nct_id>
  </id_info>
  <brief_title>COVID-19 Virtual Care at Home</brief_title>
  <official_title>COVID-19 Virtual Care at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiac Arrhythmia Network of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multicentre prospective cohort trial is designed to demonstrate effectiveness and&#xD;
      efficiency of a virtual care model for the management of COVID-19 patients isolating at home.&#xD;
      The investigators have reoriented existing technology and networks for this research project.&#xD;
      The investigators are amplifying our existing virtual care platform VIRTUES, combining it&#xD;
      with home monitoring of COVID-19 patients, to provide real-time evidence, harmonize data&#xD;
      collection, and share data provincially to mitigate the impact of the rapid spread of the&#xD;
      virus. The study will facilitate early detection of complications associated with the&#xD;
      disease, treatment and management of COVID-19 patients at home. The research will be&#xD;
      conducted provincially in Ontario.&#xD;
&#xD;
      This initiative will provide evidence to inform clinical and health system management and&#xD;
      public health response to COVID-19 patients isolating at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">February 4, 2022</completion_date>
  <primary_completion_date type="Actual">February 4, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective non-randomized cohort study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>14 Day Patient Satisfaction Questionnaire</measure>
    <time_frame>14 days</time_frame>
    <description>The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Department Visits</measure>
    <time_frame>14 days</time_frame>
    <description>The secondary outcome measures will include the number of patients that require an Emergency Department visits during the observation period of 14 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>14 Day EQ-5D-5L Scores</measure>
    <time_frame>14 days</time_frame>
    <description>The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at 14 days. Scoring is Level 1 to 5 for each dimension; higher scores meaning worse health status.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">817</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>COVID-19 Virtual Care at Home</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>VIRTUES COVID-19 Care at Home Platform&#xD;
The components of the platform will include:&#xD;
Vital sign monitoring, including O2 saturation with a home-based pulse oximeter, temperature and respiratory rate performed three times per day (a notification to do this will be sent from the app), with the option of doing assessments more frequently if needed. Study patients will be provided monitoring devices to collect this data.&#xD;
Symptom logs will be entered by the patients.&#xD;
Feedback to the patient by the local COVID-19 care team for any action:&#xD;
Two-way communication between the patient and the COVID-19 care team&#xD;
Ability for team members to see all prior notes in order to have continuity of care&#xD;
Reports of these interactions are transmitted to the patient's health record&#xD;
Current information on COVID-19 as per the Public Health Agency of Canada</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Care at Home</intervention_name>
    <description>Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home</description>
    <arm_group_label>COVID-19 Virtual Care at Home</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All COVID-19 positive patients of age 18 or above&#xD;
&#xD;
          -  Participant must communicate in English or French language&#xD;
&#xD;
          -  An email address and account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Mary's General Hospital</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Heart Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niagara Health</name>
      <address>
        <city>St. Catharines</city>
        <state>Ontario</state>
        <zip>L2S 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6R1B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Anthony Tang</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>VIRTUES</keyword>
  <keyword>Virtual Care Management</keyword>
  <keyword>Virtual Care</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Emergency Visits</keyword>
  <keyword>Oxygen Saturation</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04420182
org study id: CTO 3210
nct id: NCT04420182
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This multicentre prospective cohort trial is designed to demonstrate effectiveness and
      efficiency of a virtual care model for the management of COVID-19 patients isolating at home.
      The investigators have reoriented existing technology and networks for this research project.
      The investigators are amplifying our existing virtual care platform VIRTUES, combining it
      with home monitoring of COVID-19 patients, to provide real-time evidence, harmonize data
      collection, and share data provincially to mitigate the impact of the rapid spread of the
      virus. The study will facilitate early detection of complications associated with the
      disease, treatment and management of COVID-19 patients at home. The research will be
      conducted provincially in Ontario.

      This initiative will provide evidence to inform clinical and health system management and
      public health response to COVID-19 patients isolating at home.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective non-randomized cohort study
primary purpose: Treatment
masking: None (Open Label)
measure: 14 Day Patient Satisfaction Questionnaire
time frame: 14 days
description: The primary outcome measure is patient satisfaction as measured from a patient satisfaction questionnaire at 14 days.
measure: Emergency Department Visits
time frame: 14 days
description: The secondary outcome measures will include the number of patients that require an Emergency Department visits during the observation period of 14 days.
measure: 14 Day EQ-5D-5L Scores
time frame: 14 days
description: The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D-5L) at 14 days. Scoring is Level 1 to 5 for each dimension; higher scores meaning worse health status.
arm group label: COVID-19 Virtual Care at Home
arm group type: Other
description: VIRTUES COVID-19 Care at Home Platform
The components of the platform will include:
Vital sign monitoring, including O2 saturation with a home-based pulse oximeter, temperature and respiratory rate performed three times per day (a notification to do this will be sent from the app), with the option of doing assessments more frequently if needed. Study patients will be provided monitoring devices to collect this data.
Symptom logs will be entered by the patients.
Feedback to the patient by the local COVID-19 care team for any action:
Two-way communication between the patient and the COVID-19 care team
Ability for team members to see all prior notes in order to have continuity of care
Reports of these interactions are transmitted to the patient's health record
Current information on COVID-19 as per the Public Health Agency of Canada
intervention type: Other
intervention name: Virtual Care at Home
description: Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home
arm group label: COVID-19 Virtual Care at Home
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Anthony Tang
investigator title: Principal Investigator
mesh term: COVID-19