<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/NCT03800329</url>
  </required_header>
  <id_info>
    <org_study_id>17-008249</org_study_id>
    <nct_id>NCT03800329</nct_id>
  </id_info>
  <brief_title>Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery</brief_title>
  <official_title>Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Snap40 Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      This study is designed to determine the perceived value of continuous remote monitoring to&#xD;
      surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether&#xD;
      algorithms can be generated to predict risk of readmission following discharge. This initial&#xD;
      study will be conducted through the Department of Cardiovascular Surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall aim of this project is to determine the perceived utility and benefit to use of&#xD;
      remote monitoring technology in patients being discharged following cardiac surgery at Mayo&#xD;
      Clinic in Rochester, MN. The investigators also aim to determine whether machine learning&#xD;
      algorithms can predict readmission following cardiac surgery in these patients, which the&#xD;
      investigators believe will benefit patients in future studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Actual">October 26, 2021</completion_date>
  <primary_completion_date type="Actual">October 26, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physician satisfaction in the use of remote monitoring technology.</measure>
    <time_frame>48 hours</time_frame>
    <description>Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction in the use of remote monitoring technology.</measure>
    <time_frame>48 hours</time_frame>
    <description>Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Algorithms useful in prediction of readmission following cardiac surgery</measure>
    <time_frame>48 hours</time_frame>
    <description>Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Remote Monitoring</condition>
  <arm_group>
    <arm_group_label>Snap40 Monitor</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Monitor</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Snap40 Monitor</intervention_name>
    <description>Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.</description>
    <arm_group_label>Snap40 Monitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Monitor</intervention_name>
    <description>Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.</description>
    <arm_group_label>No Monitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Target accrual: 100 patients&#xD;
&#xD;
        Subject population (children, adults, groups): adults undergoing coronary bypass surgery at&#xD;
        Mayo Clinic in Rochester, MN&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing isolated coronary artery bypass graft (CABG) surgery&#xD;
&#xD;
          -  Must be undergoing the procedure at Mayo Clinic in Rochester, MN&#xD;
&#xD;
          -  Must be greater than or equal to 40 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 40 years of age&#xD;
&#xD;
          -  Concomitant additional surgical procedure (e.g., CABG + valve replacement)&#xD;
&#xD;
          -  Patients with implantable pacemakers/defibrillators&#xD;
&#xD;
          -  Patients that find the device too uncomfortable to wear for 48 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan D Miller</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jordan D. Miller, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03800329
org study id: 17-008249
nct id: NCT03800329
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to determine the perceived value of continuous remote monitoring to
      surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether
      algorithms can be generated to predict risk of readmission following discharge. This initial
      study will be conducted through the Department of Cardiovascular Surgery.
The overall aim of this project is to determine the perceived utility and benefit to use of
      remote monitoring technology in patients being discharged following cardiac surgery at Mayo
      Clinic in Rochester, MN. The investigators also aim to determine whether machine learning
      algorithms can predict readmission following cardiac surgery in these patients, which the
      investigators believe will benefit patients in future studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Physician satisfaction in the use of remote monitoring technology.
time frame: 48 hours
description: Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.
measure: Patient satisfaction in the use of remote monitoring technology.
time frame: 48 hours
description: Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.
measure: Algorithms useful in prediction of readmission following cardiac surgery
time frame: 48 hours
description: Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients.
arm group label: Snap40 Monitor
arm group type: Active Comparator
description: Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.
arm group label: No Monitor
arm group type: Placebo Comparator
description: Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion.
intervention type: Device
intervention name: Snap40 Monitor
description: Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.
arm group label: Snap40 Monitor
intervention type: Other
intervention name: No Monitor
description: Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.
arm group label: No Monitor
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan D Miller
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jordan D. Miller, Ph.D.
investigator title: Principal Investigator