xml: <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/NCT06011395</url>
    </required_header>
    <id_info>
      <org_study_id>22HH7635</org_study_id>
      <nct_id>NCT06011395</nct_id>
    </id_info>
    <brief_title>Smart Watch Insights to Prevent Exacerbations and Recurrence - Health Study: SWIPER-HEALTH</brief_title>
    <acronym>SWIPER-HEALTH</acronym>
    <official_title>Smart Watch Insights to Prevent Exacerbations and Recurrence - Health Study: SWIPER-HEALTH</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Imperial College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Imperial College London</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>
        Aims of the study:&#xD;
  &#xD;
          -  To measure the rate of completion of a digital cardiac rehabilitation programme at&#xD;
             Imperial College Healthcare NHS Trust (ICHNT)&#xD;
  &#xD;
          -  To measure the health economic impact of a digital cardiac rehabilitation programme at&#xD;
             ICHNT&#xD;
  &#xD;
        Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to&#xD;
        participate. Participants will receive a commercially available smart watch and be asked to&#xD;
        wear the device as much as possible. In addition, they will be asked to download a smartphone&#xD;
        application called 'Imperial Healthy Hearts', which displays movement and information on&#xD;
        heart rate, breathing and oxygen levels to both the participant and the research team&#xD;
        (digital data). The Healthy Hearts app also allows the direct care team to provide&#xD;
        educational materials to patients as part of their routine care.&#xD;
  &#xD;
        The clinical content and structure of the CR programme is determined by the clinical CR team,&#xD;
        and does not deviate from established local and national standards and practices.&#xD;
  &#xD;
        Researchers will capture physiological data such as heart rate, respiratory rate, blood&#xD;
        pressure (where available) and oxygen saturation (where available) via the Healthy Hearts&#xD;
        platform. Researchers will also capture clinical information from the electronic health&#xD;
        record, and will compare CR programme uptake and completion rates with historical data and&#xD;
        national targets.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Uptake of cardiac rehabilitation</measure>
      <time_frame>12 months</time_frame>
      <description>Percentage uptake of cardiac rehabilitation programme (of those that are eligible)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of life assessment (EQ-5D-5L)</measure>
      <time_frame>12 months</time_frame>
      <description>Patient quality of life as measured by the EQ-5D-5L instrument</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1800</enrollment>
    <condition>Cardiovascular Diseases</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Smartwatch</intervention_name>
      <description>Activity tracker (step count, calories burned), heart rate monitor</description>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Imperial Healthy Hearts app</intervention_name>
      <description>Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 years or above&#xD;
  &#xD;
            -  Able to give informed consent&#xD;
  &#xD;
            -  Eligible for Cardiac Rehabilitation programme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any wrist wound, skin pathology or other feature that would prohibit the wearing of a&#xD;
               smartwatch&#xD;
  &#xD;
            -  Any visual impairment preventing the use of the Fitbit or smartphone application.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Nicholas S Peters, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Imperial College London</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Imperial College Healthcare NHS Trust</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cardiac rehabilitation</keyword>
    <keyword>Prevention</keyword>
    <keyword>Digital health</keyword>
    <keyword>Smart wearables</keyword>
    <keyword>Remote patient monitoring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011395
  org study id: 22HH7635
  nct id: NCT06011395
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aims of the study:
  
          -  To measure the rate of completion of a digital cardiac rehabilitation programme at
             Imperial College Healthcare NHS Trust (ICHNT)
  
          -  To measure the health economic impact of a digital cardiac rehabilitation programme at
             ICHNT
  
        Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to
        participate. Participants will receive a commercially available smart watch and be asked to
        wear the device as much as possible. In addition, they will be asked to download a smartphone
        application called 'Imperial Healthy Hearts', which displays movement and information on
        heart rate, breathing and oxygen levels to both the participant and the research team
        (digital data). The Healthy Hearts app also allows the direct care team to provide
        educational materials to patients as part of their routine care.
  
        The clinical content and structure of the CR programme is determined by the clinical CR team,
        and does not deviate from established local and national standards and practices.
  
        Researchers will capture physiological data such as heart rate, respiratory rate, blood
        pressure (where available) and oxygen saturation (where available) via the Healthy Hearts
        platform. Researchers will also capture clinical information from the electronic health
        record, and will compare CR programme uptake and completion rates with historical data and
        national targets.
  observational model: Cohort
  time perspective: Prospective
  measure: Uptake of cardiac rehabilitation
  time frame: 12 months
  description: Percentage uptake of cardiac rehabilitation programme (of those that are eligible)
  measure: Quality of life assessment (EQ-5D-5L)
  time frame: 12 months
  description: Patient quality of life as measured by the EQ-5D-5L instrument
  intervention type: Device
  intervention name: Smartwatch
  description: Activity tracker (step count, calories burned), heart rate monitor
  intervention type: Device
  intervention name: Imperial Healthy Hearts app
  description: Digital cardiac rehabilitation smartphone application. Represents smart watch data and source of educational materials for cardiac rehabilitiation programme.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Nicholas S Peters, MD
  role: Principal Investigator
  affiliation: Imperial College London
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Cardiovascular Diseases
  mesh term: Recurrence
  sharing ipd: Undecided