<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/NCT03253549</url>
  </required_header>
  <id_info>
    <org_study_id>SMArTVIEW v1.0</org_study_id>
    <nct_id>NCT03253549</nct_id>
  </id_info>
  <brief_title>THE SMArTVIEW, CoVeRed</brief_title>
  <acronym>SMArTVIEW</acronym>
  <official_title>TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Centres of Excellence</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</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>
      The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at&#xD;
      home, on patients undergoing cardiac and major vascular surgery, to determine the effect on&#xD;
      the 45-day risk of a composite of hospital readmission and emergency department/urgent care&#xD;
      centre visits (not requiring hospital admission). Half of participants will receive the&#xD;
      SMArTVIEW intervention of increased monitoring, while the other half will receive standard&#xD;
      care after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated&#xD;
      monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention&#xD;
      program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the&#xD;
      surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign&#xD;
      monitoring devices that are worn during their entire stay on the surgical unit (blood&#xD;
      pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are&#xD;
      sent via handheld device to the primary care nurse for early intervention.&#xD;
&#xD;
      With a view to seamless transition home, Stage 2 supports these individuals at home during&#xD;
      the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring&#xD;
      equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight&#xD;
      scale. From home, the tablet uploads patients' vital signs and measurements automatically and&#xD;
      sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back&#xD;
      at the hospital. The tablet interface also prompts patients to respond to brief, easy to&#xD;
      read, daily surveys in order to inform the nurse about their status. The tablet also supports&#xD;
      secure daily video visits and daily interaction with the nurse for postoperative assessment&#xD;
      and support, surgical wound photographs, as well as patient access to customized educational&#xD;
      materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 21, 2018</start_date>
  <completion_date type="Anticipated">December 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 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>
    <intervention_model_description>Participants are randomized to SMArTVIEW or Standard Care.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Readmission Rate</measure>
    <time_frame>Readmission within 45 days post discharge.</time_frame>
    <description>45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of Major Complications associated with Undetected Hemodynamic Compromise</measure>
    <time_frame>45 day and 6 months post discharge</time_frame>
    <description>Composite death, non-fatal myocardial infarction, non-fatal stroke, non-fatal cardiac arrest, congestive heart failure, clinically important atrial fibrillation, deep vein thrombosis or pulmonary embolism, bleeding, respiratory failure, falls, delirium, reoperation, important hypotension, acute kidney injury w/ dialysis, infection/sepsis and medication error detection and correction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User Experience while on the SMArTVIEW Intervention compared to standard of care</measure>
    <time_frame>45 days and 6 months post discharge.</time_frame>
    <description>Patient and clinician experience, family/caregiver experience, patient's functional status, patient activation, postoperative pain and satisfaction with care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Econometrics</measure>
    <time_frame>45 days and 6 months post discharge.</time_frame>
    <description>Health service utilization-related costs and patient-level of cost of recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Process &amp; Implementation</measure>
    <time_frame>Through study completion. An average of 1 year.</time_frame>
    <description>Barriers and facilitators to the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">572</enrollment>
  <condition>Surgery (Cardiac)</condition>
  <condition>Surgery (Major Vascular)</condition>
  <arm_group>
    <arm_group_label>SMArTVIEW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SMArTVIEW</intervention_name>
    <description>Remote automated, continuous monitoring in hospital after cardiac or vascular surgery, followed by 30-day at home monitoring, daily nurse video visits and a self-management training program.</description>
    <arm_group_label>SMArTVIEW</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 60 years;&#xD;
&#xD;
          2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op&#xD;
             to the surgical floor;&#xD;
&#xD;
          3. Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;&#xD;
&#xD;
          4. Patient has a negative Confusion Assessment Method (CAM) test result preceding, or&#xD;
             within 12 hours of arriving on the surgical floor and is randomized within the first&#xD;
             24 hours after arriving on the ward;&#xD;
&#xD;
          5. Patient is able to provide consent autonomously.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is unable to communicate with research staff, complete surveys and&#xD;
             questionnaires, or a telephone interview;&#xD;
&#xD;
          2. Patient has an intolerance/allergy to adhesive;&#xD;
&#xD;
          3. Patient unable to complete 30 days of at-home follow up due to current or planned&#xD;
             relocation to nursing home or rehab facility; and&#xD;
&#xD;
          4. Patients with radial graft sites&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Heart &amp; Chest Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>England</state>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>remote automated monitoring</keyword>
  <keyword>hospital to home virtual care</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>major vascular surgery</keyword>
  <keyword>self-management</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03253549
org study id: SMArTVIEW v1.0
nct id: NCT03253549
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at
      home, on patients undergoing cardiac and major vascular surgery, to determine the effect on
      the 45-day risk of a composite of hospital readmission and emergency department/urgent care
      centre visits (not requiring hospital admission). Half of participants will receive the
      SMArTVIEW intervention of increased monitoring, while the other half will receive standard
      care after surgery.
SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated
      monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention
      program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the
      surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign
      monitoring devices that are worn during their entire stay on the surgical unit (blood
      pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are
      sent via handheld device to the primary care nurse for early intervention.

      With a view to seamless transition home, Stage 2 supports these individuals at home during
      the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring
      equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight
      scale. From home, the tablet uploads patients' vital signs and measurements automatically and
      sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back
      at the hospital. The tablet interface also prompts patients to respond to brief, easy to
      read, daily surveys in order to inform the nurse about their status. The tablet also supports
      secure daily video visits and daily interaction with the nurse for postoperative assessment
      and support, surgical wound photographs, as well as patient access to customized educational
      materials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomized to SMArTVIEW or Standard Care.
primary purpose: Prevention
masking: None (Open Label)
measure: Hospital Readmission Rate
time frame: Readmission within 45 days post discharge.
description: 45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).
measure: Composite of Major Complications associated with Undetected Hemodynamic Compromise
time frame: 45 day and 6 months post discharge
description: Composite death, non-fatal myocardial infarction, non-fatal stroke, non-fatal cardiac arrest, congestive heart failure, clinically important atrial fibrillation, deep vein thrombosis or pulmonary embolism, bleeding, respiratory failure, falls, delirium, reoperation, important hypotension, acute kidney injury w/ dialysis, infection/sepsis and medication error detection and correction.
measure: User Experience while on the SMArTVIEW Intervention compared to standard of care
time frame: 45 days and 6 months post discharge.
description: Patient and clinician experience, family/caregiver experience, patient's functional status, patient activation, postoperative pain and satisfaction with care.
measure: Econometrics
time frame: 45 days and 6 months post discharge.
description: Health service utilization-related costs and patient-level of cost of recovery.
measure: Process & Implementation
time frame: Through study completion. An average of 1 year.
description: Barriers and facilitators to the intervention
arm group label: SMArTVIEW
arm group type: Experimental
arm group label: Standard Care
arm group type: No Intervention
intervention type: Device
intervention name: SMArTVIEW
description: Remote automated, continuous monitoring in hospital after cardiac or vascular surgery, followed by 30-day at home monitoring, daily nurse video visits and a self-management training program.
arm group label: SMArTVIEW
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Canada
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided