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/NCT06034392</url>
    </required_header>
    <id_info>
      <org_study_id>15030113CMH</org_study_id>
      <nct_id>NCT06034392</nct_id>
    </id_info>
    <brief_title>CHAMP App Cardiac Study and Repository</brief_title>
    <acronym>CHAMP</acronym>
    <official_title>CHAMP App Cardiac Study: Evaluation of Software Functions for Asynchronous Monitoring of Children With Complex Congenital Heart Disease in the Home Setting and Data Repository</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lori Erickson</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Mercy Hospital Kansas City</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multi-site research study with an optional research repository that will consist of&#xD;
        clinically derived data and photographic or video images of patients in the home setting with&#xD;
        complex health conditions to evaluate the safety and efficacy of the CHAMP® software&#xD;
        platform, with data and photographic or video images input and/or uploaded by the parent or&#xD;
        other legally authorized representative (LAR) of patients with complex congenital heart&#xD;
        disease as a target population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study objectives&#xD;
  &#xD;
          1. To evaluate whether data collection and transmission through the CHAMP software platform&#xD;
             improves communication between health care providers and parents/LAR that positively&#xD;
             affects the care of children with complex congenital heart disease in which asynchronous&#xD;
             monitoring in the home setting is indicated&#xD;
  &#xD;
          2. To determine the accuracy of data obtained regarding observation by parent or caregiver&#xD;
             of the condition of children with complex congenital heart disease in which asynchronous&#xD;
             monitoring in the home setting is indicated.&#xD;
  &#xD;
          3. To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction&#xD;
             with the data entry, parental self-management, and transmission capabilities.&#xD;
  &#xD;
          4. To evaluate the real-world performance analytics (RWPA) of the CHAMP software platform&#xD;
             for transfer of parent-entered data for children with complex congenital heart disease&#xD;
             in which asynchronous monitoring in the home setting is indicated.&#xD;
  &#xD;
        Endpoints&#xD;
  &#xD;
          1. To demonstrate that parents and caregivers for children with complex congenital heart&#xD;
             disease in which asynchronous monitoring in the home setting is indicated can accurately&#xD;
             identify and transmit to healthcare providers specific health-related data including&#xD;
             intake of food, fluids and mediations; output, including urination, defecation, and&#xD;
             vomiting; weight; vital signs including oxygen saturation as measured by pulse oximetry;&#xD;
             heart rate as measured either by a heart rate monitor or manually by the parent or&#xD;
             caregiver; and temperature, measured by a reliable thermometer; and the value and&#xD;
             reliability of videos provided by parents and caregivers regarding behavior of pediatric&#xD;
             study participants for use in evaluating participant's health status.&#xD;
  &#xD;
          2. To demonstrate that data obtained through the use of devices such as pulse oximeters, as&#xD;
             entered into the app by parents and caregivers, provide valuable information regarding&#xD;
             the health status of children with Complex Diagnoses in a home setting.&#xD;
  &#xD;
          3. To demonstrate characteristics of CHAMP through real world health analytics (RWHA), user&#xD;
             experience analytics (UX), and product performance analytics (PPA).&#xD;
  &#xD;
        The study duration is open-ended for safety, effectiveness, and performance of the CHAMP app.&#xD;
        Unless consent is withdrawn, data will be kept and used for data analysis and, if consented&#xD;
        to the research repository for multi-site research purposes indefinitely. At age 18,&#xD;
        previously pediatric patients may be approached for reconsent.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 25, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Human factors/usability engineering: Login failures</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Rate of attempts of log-in failures</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Human factors/usability engineering: Imprecision</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Rate of data values reported with imprecision</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Safety: Anticipated adverse events</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Anticipated Adverse event rates</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Safety: Event resolution- anticipated</measure>
      <time_frame>Time in days, reported over the last 3 months</time_frame>
      <description>Time to resolve anticipated adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Safety: Unanticipated Adverse events</measure>
      <time_frame>Time in days, reported over the last 3 months</time_frame>
      <description>Unanticipated adverse event rates</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical Safety: Event resolution- unanticipated</measure>
      <time_frame>Time in days, reported over the last 3 months</time_frame>
      <description>Time to resolve unanticipated adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Health Benefits: Adherence</measure>
      <time_frame>Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period</time_frame>
      <description>Rate of adherence to daily data entry</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User Satisfaction: Complaints</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Complaint rates via the healthcare team web portal</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User Satisfaction CHAMP Video</measure>
      <time_frame>through study completion, an average of 9 months</time_frame>
      <description>Feedback from healthcare team will be received via treatment endpoint survey questions. Likert scale questions 1-strongly disagree to 5 strongly agree (Using CHAMP videos for the interstage monitoring of this patient improved clinical decisions for the home monitoring team). Available to put in comments.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User Satisfaction: Communication</measure>
      <time_frame>through study completion, an average of 9 months</time_frame>
      <description>Feedback from healthcare team will be received via treatment endpoint survey questions Likert scale questions 1-strongly disagree to 5 strongly agree ( Using CHAMP for the interstage monitoring of this patient improved communication with the parents at home.) Available to put in comments.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User Engagement</measure>
      <time_frame>Over a 3 month perriod</time_frame>
      <description>Total number of registered users (Active, treatment endpoint reached) and data totals per parent entered measure. De-identified Demographics and age areas utilization -Utilization across the number of pediatric sites, healthcare teams</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CHAMP app performance: Downtime</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Product Performance Analytics measured through Any system downtime</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CHAMP app performance: Cybersecurity</measure>
      <time_frame>Over a 3 month period</time_frame>
      <description>Product Performance Analytics measured through Any reported breaches</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CHAMP app performance</measure>
      <time_frame>Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required</time_frame>
      <description>Product Performance Analytics measured through --Bug/defect rate or Version failure rates</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Heart Defects, Congenital</condition>
    <condition>Pediatrics</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CHAMP App</intervention_name>
      <description>CHAMP® App is a downloadable software mobile Application with a Software Platform. CHAMP® App is an electronic version of data entry for children with conditions that require close monitoring from their homes. The primary Intended Use is to relay monitoring information from homes to the health care team. This monitoring includes data options that can facilitate the collection of monitoring data of children in the home setting to improve communications between parents at home and remote caregivers. The CHAMP® App itself does not do home monitoring of the child's medical condition. It is not designed to alert parents if data entered has reached a red flag (problem) level. Users of the CHAMP App are advised in writing and in the informed consent process that urgent medical conditions should not be managed through the CHAMP App, and that appropriate emergency care should be obtained directly rather than through the CHAMP App.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients with complex congenital heart disease in which asynchronous monitoring&#xD;
          in the home setting is indicated in the home setting through a multi-regional approach.&#xD;
  &#xD;
          Parents who utilize their CHAMP App and the healthcare team that log-in are also part of&#xD;
          the CHAMP App study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 0-17 years with a parent/Legally authorized representative&#xD;
  &#xD;
            -  Diagnosed with a complex health condition in which asynchronous monitoring in the home&#xD;
               setting is appropriate.&#xD;
  &#xD;
            -  Pediatric patient's cardiac care team has decided that the patient's treatment plan&#xD;
               may benefit from remote home monitoring.&#xD;
  &#xD;
            -  Institution that the subject is followed through clinically has been an approved as&#xD;
               site for the CHAMP app study with Children's Mercy Kansas City.&#xD;
  &#xD;
          Adult participants&#xD;
  &#xD;
            -  Parents/Legally authorized representatives of pediatric subject.&#xD;
  &#xD;
            -  Healthcare team users at an institution that is an approved site for the CHAMP app&#xD;
               Study with Children's Mercy Kansas City.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to be discharged to care in the home setting.&#xD;
  &#xD;
            -  Those not meeting the above inclusion criteria.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>18 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>
    <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>
    <reference>
      <citation>Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.</citation>
      <PMID>27166202</PMID>
    </reference>
    <reference>
      <citation>Bingler M, Erickson LA, Reid KJ, Lee B, O'Brien J, Apperson J, Goggin K, Shirali G. Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study. World J Pediatr Congenit Heart Surg. 2018 May;9(3):305-314. doi: 10.1177/2150135118762401.</citation>
      <PMID>29692236</PMID>
    </reference>
    <reference>
      <citation>Aly DM, Erickson LA, Hancock H, Apperson JW, Gaddis M, Shirali G, Goudar S. Ability of Video Telemetry to Predict Unplanned Hospital Admissions for Single Ventricle Infants. J Am Heart Assoc. 2021 Aug 17;10(16):e020851. doi: 10.1161/JAHA.121.020851. Epub 2021 Aug 7.</citation>
      <PMID>34365801</PMID>
    </reference>
    <reference>
      <citation>Erickson LA, Emerson A, Russell CL. Parental mobile health adherence to symptom home monitoring for infants with congenital heart disease during the single ventricle interstage period: A concept analysis. J Spec Pediatr Nurs. 2020 Oct;25(4):e12303. doi: 10.1111/jspn.12303. Epub 2020 Jul 14.</citation>
      <PMID>32662243</PMID>
    </reference>
    <reference>
      <citation>Patel PS, Shah SK, Feldman K, Hancock HS, Moehlmann ML, Ricketts A, Files MD, McFarland C, Erickson L, Romans RA. Associations of Home Monitoring Data to Interventional Catheterization for Infants with Recurrent Coarctation of the Aorta and Hypoplastic Left Heart Syndrome. Pediatr Cardiol. 2023 Oct;44(7):1462-1470. doi: 10.1007/s00246-023-03224-8. Epub 2023 Jul 8.</citation>
      <PMID>37421465</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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>Sponsor-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>mHealth</keyword>
    <keyword>Software Platform</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Congenital Abnormalities</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/NCT06034392
  org study id: 15030113CMH
  nct id: NCT06034392
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This is a multi-site research study with an optional research repository that will consist of
        clinically derived data and photographic or video images of patients in the home setting with
        complex health conditions to evaluate the safety and efficacy of the CHAMP® software
        platform, with data and photographic or video images input and/or uploaded by the parent or
        other legally authorized representative (LAR) of patients with complex congenital heart
        disease as a target population.
  Study objectives
  
          1. To evaluate whether data collection and transmission through the CHAMP software platform
             improves communication between health care providers and parents/LAR that positively
             affects the care of children with complex congenital heart disease in which asynchronous
             monitoring in the home setting is indicated
  
          2. To determine the accuracy of data obtained regarding observation by parent or caregiver
             of the condition of children with complex congenital heart disease in which asynchronous
             monitoring in the home setting is indicated.
  
          3. To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction
             with the data entry, parental self-management, and transmission capabilities.
  
          4. To evaluate the real-world performance analytics (RWPA) of the CHAMP software platform
             for transfer of parent-entered data for children with complex congenital heart disease
             in which asynchronous monitoring in the home setting is indicated.
  
        Endpoints
  
          1. To demonstrate that parents and caregivers for children with complex congenital heart
             disease in which asynchronous monitoring in the home setting is indicated can accurately
             identify and transmit to healthcare providers specific health-related data including
             intake of food, fluids and mediations; output, including urination, defecation, and
             vomiting; weight; vital signs including oxygen saturation as measured by pulse oximetry;
             heart rate as measured either by a heart rate monitor or manually by the parent or
             caregiver; and temperature, measured by a reliable thermometer; and the value and
             reliability of videos provided by parents and caregivers regarding behavior of pediatric
             study participants for use in evaluating participant's health status.
  
          2. To demonstrate that data obtained through the use of devices such as pulse oximeters, as
             entered into the app by parents and caregivers, provide valuable information regarding
             the health status of children with Complex Diagnoses in a home setting.
  
          3. To demonstrate characteristics of CHAMP through real world health analytics (RWHA), user
             experience analytics (UX), and product performance analytics (PPA).
  
        The study duration is open-ended for safety, effectiveness, and performance of the CHAMP app.
        Unless consent is withdrawn, data will be kept and used for data analysis and, if consented
        to the research repository for multi-site research purposes indefinitely. At age 18,
        previously pediatric patients may be approached for reconsent.
  observational model: Cohort
  time perspective: Other
  measure: Human factors/usability engineering: Login failures
  time frame: Over a 3 month period
  description: Rate of attempts of log-in failures
  measure: Human factors/usability engineering: Imprecision
  time frame: Over a 3 month period
  description: Rate of data values reported with imprecision
  measure: Clinical Safety: Anticipated adverse events
  time frame: Over a 3 month period
  description: Anticipated Adverse event rates
  measure: Clinical Safety: Event resolution- anticipated
  time frame: Time in days, reported over the last 3 months
  description: Time to resolve anticipated adverse events
  measure: Clinical Safety: Unanticipated Adverse events
  time frame: Time in days, reported over the last 3 months
  description: Unanticipated adverse event rates
  measure: Clinical Safety: Event resolution- unanticipated
  time frame: Time in days, reported over the last 3 months
  description: Time to resolve unanticipated adverse events
  measure: Health Benefits: Adherence
  time frame: Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period
  description: Rate of adherence to daily data entry
  measure: User Satisfaction: Complaints
  time frame: Over a 3 month period
  description: Complaint rates via the healthcare team web portal
  measure: User Satisfaction CHAMP Video
  time frame: through study completion, an average of 9 months
  description: Feedback from healthcare team will be received via treatment endpoint survey questions. Likert scale questions 1-strongly disagree to 5 strongly agree (Using CHAMP videos for the interstage monitoring of this patient improved clinical decisions for the home monitoring team). Available to put in comments.
  measure: User Satisfaction: Communication
  time frame: through study completion, an average of 9 months
  description: Feedback from healthcare team will be received via treatment endpoint survey questions Likert scale questions 1-strongly disagree to 5 strongly agree ( Using CHAMP for the interstage monitoring of this patient improved communication with the parents at home.) Available to put in comments.
  measure: User Engagement
  time frame: Over a 3 month perriod
  description: Total number of registered users (Active, treatment endpoint reached) and data totals per parent entered measure. De-identified Demographics and age areas utilization -Utilization across the number of pediatric sites, healthcare teams
  measure: CHAMP app performance: Downtime
  time frame: Over a 3 month period
  description: Product Performance Analytics measured through Any system downtime
  measure: CHAMP app performance: Cybersecurity
  time frame: Over a 3 month period
  description: Product Performance Analytics measured through Any reported breaches
  measure: CHAMP app performance
  time frame: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required
  description: Product Performance Analytics measured through --Bug/defect rate or Version failure rates
  intervention type: Device
  intervention name: CHAMP App
  description: CHAMP® App is a downloadable software mobile Application with a Software Platform. CHAMP® App is an electronic version of data entry for children with conditions that require close monitoring from their homes. The primary Intended Use is to relay monitoring information from homes to the health care team. This monitoring includes data options that can facilitate the collection of monitoring data of children in the home setting to improve communications between parents at home and remote caregivers. The CHAMP® App itself does not do home monitoring of the child's medical condition. It is not designed to alert parents if data entered has reached a red flag (problem) level. Users of the CHAMP App are advised in writing and in the informed consent process that urgent medical conditions should not be managed through the CHAMP App, and that appropriate emergency care should be obtained directly rather than through the CHAMP App.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 18 Years
  healthy volunteers: No
  last name: Lori Erickson, PhD
  role: Principal Investigator
  affiliation: Director, Remote Health Solutions Children's Mercy
  facility: 
  country: United States
  citation: Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.
  PMID: 27166202
  citation: Bingler M, Erickson LA, Reid KJ, Lee B, O'Brien J, Apperson J, Goggin K, Shirali G. Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study. World J Pediatr Congenit Heart Surg. 2018 May;9(3):305-314. doi: 10.1177/2150135118762401.
  PMID: 29692236
  citation: Aly DM, Erickson LA, Hancock H, Apperson JW, Gaddis M, Shirali G, Goudar S. Ability of Video Telemetry to Predict Unplanned Hospital Admissions for Single Ventricle Infants. J Am Heart Assoc. 2021 Aug 17;10(16):e020851. doi: 10.1161/JAHA.121.020851. Epub 2021 Aug 7.
  PMID: 34365801
  citation: Erickson LA, Emerson A, Russell CL. Parental mobile health adherence to symptom home monitoring for infants with congenital heart disease during the single ventricle interstage period: A concept analysis. J Spec Pediatr Nurs. 2020 Oct;25(4):e12303. doi: 10.1111/jspn.12303. Epub 2020 Jul 14.
  PMID: 32662243
  citation: Patel PS, Shah SK, Feldman K, Hancock HS, Moehlmann ML, Ricketts A, Files MD, McFarland C, Erickson L, Romans RA. Associations of Home Monitoring Data to Interventional Catheterization for Infants with Recurrent Coarctation of the Aorta and Hypoplastic Left Heart Syndrome. Pediatr Cardiol. 2023 Oct;44(7):1462-1470. doi: 10.1007/s00246-023-03224-8. Epub 2023 Jul 8.
  PMID: 37421465
  responsible party type: Sponsor-Investigator
  investigator affiliation: Children's Mercy Hospital Kansas City
  investigator full name: Lori Erickson
  investigator title: Director, Remote Health Solutions
  mesh term: Heart Defects, Congenital
  mesh term: Congenital Abnormalities
  sharing ipd: Undecided