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/NCT05975658</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002554</org_study_id>
      <nct_id>NCT05975658</nct_id>
    </id_info>
    <brief_title>WIReD: Wireless Interstage Remote Device Study</brief_title>
    <acronym>WIReD</acronym>
    <official_title>WIReD: Wireless Interstage Remote Device Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Mercy Hospital Kansas City</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gabi SmartCare</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</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>
        A mixed-methods study will be used to evaluate the use of standard of care periodic pulse&#xD;
        oximetry by parents/LAR and the feasibility of the collection of physiologic data related to&#xD;
        the use of the Pediarity System. This system includes the Gabi Band and software platform&#xD;
        (Gabi Analytics).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After enrollment, parents will be taught by the study team on the use of the Pediarity System&#xD;
        which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor&#xD;
        application for data transfer. This education by the study team will ensure uniform training&#xD;
        and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi&#xD;
        monitoring application. Parents can ask the study team any use and/or technical questions&#xD;
        during this time period. All clinical care questions from standard of care monitoring will go&#xD;
        to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the&#xD;
        Pediarity System - they will be referred to use their standard of care pulse oximetry before&#xD;
        any clinical intervention and care is recommended by the healthcare team. The study team will&#xD;
        not make any healthcare or diagnostic recommendations during the monitoring period based on&#xD;
        any Pediarity System data.&#xD;
  &#xD;
        The study team will educate parents and LARs on the Pediarity System. This system does not&#xD;
        replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place&#xD;
        the Gabi band on their child and use the Pediarity System at any frequency they choose in the&#xD;
        home setting for a length of approximately one month at home (to coordinate when they return&#xD;
        to the study site for a care visit). Parents can email or Teams call the study team directly&#xD;
        (during daytime hours M-F) for any technical questions during this the study period. The&#xD;
        study team will evaluate clinical data only at the conclusion of the study period and&#xD;
        qualitative feedback from the parents will be gathered.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>Parental Experience Evaluation</measure>
      <time_frame>3-6 Weeks</time_frame>
      <description>Rigorously explore the parental experience of utilizing a continuous pediatric wireless device for monitoring at home pulse oximetry compared with standard of care periodic pulse oximetry through parent interviews.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Data Transfer Rate Evaluation</measure>
      <time_frame>3-6 Weeks</time_frame>
      <description>Evaluate the rate of data transfer from a wireless continuous monitoring device night ± daytime vs. standard of care periodic pulse oximetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stakeholder Experience Assessment</measure>
      <time_frame>3-6 Weeks</time_frame>
      <description>Assess the technology experience for stakeholders with a wireless continuous monitoring device at home vs. standard of care periodic pulse oximetry using healthcare provider interviews to discuss outcome experience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Data Threshold Event Rate Evaluation</measure>
      <time_frame>3-6 Weeks</time_frame>
      <description>Evaluate the rate of data threshold events with continuous remote device monitoring at home vs. intermittent pulse oximetry via standard of care periodic pulse oximetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effectiveness with the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comfort with the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Easy to use the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Easy to find information within the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visualization of information within the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clear organization of information within the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functions of the System</measure>
      <time_frame>3-6 weeks</time_frame>
      <description>Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7</description>
    </secondary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Congenital Heart Disease in Children</condition>
    <condition>Vital Signs</condition>
    <condition>Pediatrics</condition>
    <condition>Remote Monitoring</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]</intervention_name>
      <description>Gabi SmartCare has created a monitoring system named Pediarity System that obtains pediatric vitals data through non-invasive means through a Gabi band. When paired with a proprietary algorithm and software - Gabi Analytics - the cloud-based platform measures blood oxygen levels, pulse rate (and variability), respiratory rate, actigraphy, inter-beat interval, and tracking for the time the device is worn (or not worn by the child). Three LEDs on the monitor are used for capturing this information. Peak wavelengths for the red, infrared, and green LEDs operate at 660nm, 950nm, and 526nm respectively. The Gabi band features an optical front end coupled with an analog front end using 24 bits. Bluetooth data transmission is utilized on a mobile phone application with a tablet-based system in a CSV format for the purpose of offline data processing.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Maximum of 15 infants in the congenital, arrhythmic, or acquired heart disease population&#xD;
          to be enrolled at Children's Mercy Hospital Kansas City.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Study participants will be parent-child dyads - pediatric patients who have been&#xD;
               diagnosed with congenital, arrhythmic, or acquired heart disease at Children's Mercy&#xD;
               Kansas City.&#xD;
  &#xD;
            -  Age criteria for children: after birth and who are less than two years of age at the&#xD;
               time of being approached.&#xD;
  &#xD;
            -  Age criteria for parents or legally authorized representatives (LAR's): one&#xD;
               participating parent or LAR will be 18 years of age or older to consent at the time of&#xD;
               being approached&#xD;
  &#xD;
            -  The child of the parent-child dyad must be planned from the clinical standpoint prior&#xD;
               to approach for discharge home with standard of care oxygen saturation/heart&#xD;
               rate/pulse oximeter for remote patient monitoring population - and followed with the&#xD;
               CHAMP application in the home setting.&#xD;
  &#xD;
            -  CHAMP App CM IRB 15030113 - Pediatric patients must be utilizing the CHAMP app&#xD;
               clinically&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Over two years of age at the time of being approached for study participation.&#xD;
  &#xD;
            -  A child with no parents or LAR over age of 18 at the time the study team would&#xD;
               approach the family.&#xD;
  &#xD;
            -  Non-English-speaking families.&#xD;
  &#xD;
            -  Families that do not have access to a Wi-Fi network at home.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>2 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lori Erickson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Director, Remote Health Solutions Children's Mercy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ryan Thompson</last_name>
      <phone>8162343000</phone>
      <email>rmthompson@cmh.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's Mercy Hospital</name>
        <address>
          <city>Kansas City</city>
          <state>Missouri</state>
          <zip>64108</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://gabismartcare.com/</url>
      <description>Gabi SmartCare Website</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
      <investigator_full_name>Lori Erickson</investigator_full_name>
      <investigator_title>Director, Remote Health Solutions</investigator_title>
    </responsible_party>
    <keyword>Pediatric</keyword>
    <keyword>Physiologic vital signs</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05975658
  org study id: STUDY00002554
  nct id: NCT05975658
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A mixed-methods study will be used to evaluate the use of standard of care periodic pulse
        oximetry by parents/LAR and the feasibility of the collection of physiologic data related to
        the use of the Pediarity System. This system includes the Gabi Band and software platform
        (Gabi Analytics).
  After enrollment, parents will be taught by the study team on the use of the Pediarity System
        which includes the placement of the Gabi Band and the use of the Gabi Wi-Fi monitor
        application for data transfer. This education by the study team will ensure uniform training
        and preliminary understanding with teach back on the use of the Gabi band and Gabi Wi-Fi
        monitoring application. Parents can ask the study team any use and/or technical questions
        during this time period. All clinical care questions from standard of care monitoring will go
        to the CHAMP healthcare team. If parents/LARs have a clinical concern from a value on the
        Pediarity System - they will be referred to use their standard of care pulse oximetry before
        any clinical intervention and care is recommended by the healthcare team. The study team will
        not make any healthcare or diagnostic recommendations during the monitoring period based on
        any Pediarity System data.
  
        The study team will educate parents and LARs on the Pediarity System. This system does not
        replace any use of their standard of care pulse oximetry and CHAMP videos. Parents may place
        the Gabi band on their child and use the Pediarity System at any frequency they choose in the
        home setting for a length of approximately one month at home (to coordinate when they return
        to the study site for a care visit). Parents can email or Teams call the study team directly
        (during daytime hours M-F) for any technical questions during this the study period. The
        study team will evaluate clinical data only at the conclusion of the study period and
        qualitative feedback from the parents will be gathered.
  observational model: Cohort
  time perspective: Prospective
  measure: Parental Experience Evaluation
  time frame: 3-6 Weeks
  description: Rigorously explore the parental experience of utilizing a continuous pediatric wireless device for monitoring at home pulse oximetry compared with standard of care periodic pulse oximetry through parent interviews.
  measure: Data Transfer Rate Evaluation
  time frame: 3-6 Weeks
  description: Evaluate the rate of data transfer from a wireless continuous monitoring device night ± daytime vs. standard of care periodic pulse oximetry.
  measure: Stakeholder Experience Assessment
  time frame: 3-6 Weeks
  description: Assess the technology experience for stakeholders with a wireless continuous monitoring device at home vs. standard of care periodic pulse oximetry using healthcare provider interviews to discuss outcome experience.
  measure: Data Threshold Event Rate Evaluation
  time frame: 3-6 Weeks
  description: Evaluate the rate of data threshold events with continuous remote device monitoring at home vs. intermittent pulse oximetry via standard of care periodic pulse oximetry.
  measure: Satisfaction with the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Effectiveness with the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Comfort with the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Easy to use the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Easy to find information within the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Visualization of information within the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Clear organization of information within the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  measure: Functions of the System
  time frame: 3-6 weeks
  description: Using the System Usability Survey (SUS) Strongly Disagree to Strongly Agree 1-7
  intervention type: Device
  intervention name: Gabi SmartCare Pediarity System [Gabi Band, Gabi Monitor App, Gabi Analytics]
  description: Gabi SmartCare has created a monitoring system named Pediarity System that obtains pediatric vitals data through non-invasive means through a Gabi band. When paired with a proprietary algorithm and software - Gabi Analytics - the cloud-based platform measures blood oxygen levels, pulse rate (and variability), respiratory rate, actigraphy, inter-beat interval, and tracking for the time the device is worn (or not worn by the child). Three LEDs on the monitor are used for capturing this information. Peak wavelengths for the red, infrared, and green LEDs operate at 660nm, 950nm, and 526nm respectively. The Gabi band features an optical front end coupled with an analog front end using 24 bits. Bluetooth data transmission is utilized on a mobile phone application with a tablet-based system in a CSV format for the purpose of offline data processing.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 2 Years
  healthy volunteers: No
  last name: Lori Erickson, PhD
  role: Principal Investigator
  affiliation: Director, Remote Health Solutions Children's Mercy
  last name: Ryan Thompson
  phone: 8162343000
  email: rmthompson@cmh.edu
  facility: 
  country: United States
  url: https://gabismartcare.com/
  description: Gabi SmartCare Website
  responsible party type: Principal Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Lori Erickson
  investigator title: Director, Remote Health Solutions
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  sharing ipd: No