<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/NCT04471636</url>
  </required_header>
  <id_info>
    <org_study_id>20-448</org_study_id>
    <nct_id>NCT04471636</nct_id>
  </id_info>
  <brief_title>Telemedicine in Outpatient Covid-19 Patients</brief_title>
  <acronym>COVID-SMART</acronym>
  <official_title>Munich Remote SpO2 and Electrocardiogram Assessment in Covid-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gesundheitsreferat (GSR), Landeshauptstadt München</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</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>
      Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2 Coronavirus,&#xD;
      poses an increasing threat to individual health and health care systems. The individual&#xD;
      disease course ranges from mild to life threatening, the pandemic spread leads to a shortage&#xD;
      of health care resources including intensive care availability. It should be the overarching&#xD;
      goal to allocate sparse health care resources to those most at need and to simultaneously&#xD;
      avoid unnecessary blocking of resources by clinically unjustified hospitalizations.&#xD;
&#xD;
      Individuals with preexisting cardiovascular conditions are at the highest risk of health&#xD;
      deterioration, even at younger age. Objective criteria for hospitalization are not&#xD;
      immediately available in a outpatient settings. Hence, hospitalization and emergency medical&#xD;
      contact is often triggered by subjectively interpreted symptoms. The goal of this project is&#xD;
      thus to improve the availability of objective measurements in the outpatient setting by means&#xD;
      of an innovative, smartwatch mediated telemedicine approach.&#xD;
&#xD;
      To achieve this goal, the investigators will conduct a randomized clinical trial comparing a&#xD;
      smartwatch based telemedicine intervention with standard of care. The intervention group will&#xD;
      receive regular objective measurements of heart rate, ECG, and SpO2 and will get access to a&#xD;
      24/7 medical care hotline for consultation. The investigators hypothesize that the&#xD;
      intervention group will benefit by a significant reduction in unnecessary hospitalizations&#xD;
      and unplanned emergency medicine contacts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 18, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">June 27, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service</measure>
    <time_frame>30 days</time_frame>
    <description>Occurrence of any of the above during follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of participants hospitalized</measure>
    <time_frame>30 days</time_frame>
    <description>Occurrence of hospitalization during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants with unplanned use of hospital emergency department or emergency medical service</measure>
    <time_frame>30 days</time_frame>
    <description>Occurrence of any of the above during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants experiencing death of any cause</measure>
    <time_frame>30 days</time_frame>
    <description>Occurrence of death of any cause during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of participants experiencing death of Covid-19</measure>
    <time_frame>30 days</time_frame>
    <description>Occurence of daeth of Covid-19 during follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">607</enrollment>
  <condition>Covid-19</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>Telemedicine Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive assessment at baseline and at 30 day follow up. Patient receive a smart watch capeable of recording SpO2, ECG, and heart rate. Patients also receive access to 24/7 medical hotline for telemedical care. All public services of the health care system remain available.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receive assessment at baseline and at 30 day follow up. Patient have access to all services of the health care system, but do not receive a smart watch or medical hotline access.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Withings ScanWatch</intervention_name>
    <description>The smart watch is capable of recording SpO2, ECG, and heart rate.</description>
    <arm_group_label>Telemedicine Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed SARS-CoV2 infection and clinical Covid-19 disease&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
          -  Presence of ≥1 relevan cardiovascular condition, defined as (or):&#xD;
&#xD;
               -  atrial fibrillation&#xD;
&#xD;
               -  systolic or diastolic heart failure&#xD;
&#xD;
               -  LV ejection fraction &lt;50%&#xD;
&#xD;
               -  coronary artery disease with past PCI or CABG&#xD;
&#xD;
               -  Past myocardial infarction&#xD;
&#xD;
               -  diabetes mellitus&#xD;
&#xD;
               -  arterial hypertension (treated or untreated)&#xD;
&#xD;
               -  active smoking&#xD;
&#xD;
               -  chronic obstructive lung disease&#xD;
&#xD;
               -  obesity (BMI ≥30kg/m2)&#xD;
&#xD;
          -  availability of smartphone and sufficient internet connectivity at home&#xD;
&#xD;
          -  ability to use smartwatch&#xD;
&#xD;
          -  informed consent to study participation and data protection concept&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in concurrent clinical trial&#xD;
&#xD;
          -  indication for hospitalization at study entry&#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>Steffen Massberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department Head</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LMU Klinikum</name>
      <address>
        <city>Munich</city>
        <state>BY</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>June 27, 2022</last_update_submitted>
  <last_update_submitted_qc>June 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>Moritz F. Sinner</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV2</keyword>
  <keyword>Covid-19</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>telemedicine</keyword>
  <keyword>ECG</keyword>
  <keyword>SpO2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04471636
org study id: 20-448
nct id: NCT04471636
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2 Coronavirus,
      poses an increasing threat to individual health and health care systems. The individual
      disease course ranges from mild to life threatening, the pandemic spread leads to a shortage
      of health care resources including intensive care availability. It should be the overarching
      goal to allocate sparse health care resources to those most at need and to simultaneously
      avoid unnecessary blocking of resources by clinically unjustified hospitalizations.

      Individuals with preexisting cardiovascular conditions are at the highest risk of health
      deterioration, even at younger age. Objective criteria for hospitalization are not
      immediately available in a outpatient settings. Hence, hospitalization and emergency medical
      contact is often triggered by subjectively interpreted symptoms. The goal of this project is
      thus to improve the availability of objective measurements in the outpatient setting by means
      of an innovative, smartwatch mediated telemedicine approach.

      To achieve this goal, the investigators will conduct a randomized clinical trial comparing a
      smartwatch based telemedicine intervention with standard of care. The intervention group will
      receive regular objective measurements of heart rate, ECG, and SpO2 and will get access to a
      24/7 medical care hotline for consultation. The investigators hypothesize that the
      intervention group will benefit by a significant reduction in unnecessary hospitalizations
      and unplanned emergency medicine contacts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of participants with a combination of hospitalization and unplanned use of hospital emergency department or emergency medical service
time frame: 30 days
description: Occurrence of any of the above during follow-up
measure: Rate of participants hospitalized
time frame: 30 days
description: Occurrence of hospitalization during follow-up
measure: Rate of participants with unplanned use of hospital emergency department or emergency medical service
time frame: 30 days
description: Occurrence of any of the above during follow-up
measure: Rate of participants experiencing death of any cause
time frame: 30 days
description: Occurrence of death of any cause during follow-up
measure: Rate of participants experiencing death of Covid-19
time frame: 30 days
description: Occurence of daeth of Covid-19 during follow-up
arm group label: Telemedicine Care
arm group type: Experimental
description: Patients receive assessment at baseline and at 30 day follow up. Patient receive a smart watch capeable of recording SpO2, ECG, and heart rate. Patients also receive access to 24/7 medical hotline for telemedical care. All public services of the health care system remain available.
arm group label: Control
arm group type: No Intervention
description: Patients receive assessment at baseline and at 30 day follow up. Patient have access to all services of the health care system, but do not receive a smart watch or medical hotline access.
intervention type: Device
intervention name: Withings ScanWatch
description: The smart watch is capable of recording SpO2, ECG, and heart rate.
arm group label: Telemedicine Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steffen Massberg, MD
role: Study Director
affiliation: Department Head
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: Moritz F. Sinner
investigator title: Assistant Professor
mesh term: COVID-19
sharing ipd: No