<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/NCT04498728</url>
  </required_header>
  <id_info>
    <org_study_id>Study00001436</org_study_id>
    <nct_id>NCT04498728</nct_id>
  </id_info>
  <brief_title>Cardiac Acute Transitioning Care to Home (CATCH) App Data Repository</brief_title>
  <acronym>CATCH</acronym>
  <official_title>The Cardiac Acute Transitioning Care to Home (CATCH) Data Repository (CATCH App Repository)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This repository will consist of clinically derived data and images of patients with&#xD;
      congenital heart disease from the time of birth until they have reached one of the following&#xD;
      outcomes: transition to outpatient care that has not resulted in readmission in 30 days after&#xD;
      hospital discharge, death, weaned off supplementary feeding tubes, or clinic visits&#xD;
      demonstrating clinical stability with their primary cardiologist, or full bi-ventricular&#xD;
      cardiac surgery palliation with improvement in hemodynamic stability. This information will&#xD;
      be collected for clinical evaluation and diagnostic purposes and will continue to be stored&#xD;
      for potential future research application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 40,000 infants are born each year with congenital heart disease (CHD), a&#xD;
      leading cause of morbidity and mortality in infancy. Progress in surgical, transcatheter, and&#xD;
      medical management of newborn CHD has significantly reduced mortality. The CHAMP app&#xD;
      (separate IRB # 15030113) has helped to transition high-risk infants with single ventricle&#xD;
      congenital heart disease out of the hospital and to second stage cardiac surgery at&#xD;
      Children's Mercy Hospital and across the United States with improved survival. Remote&#xD;
      monitoring technology and telemedicine is a critical tool to aid clinical care for high risk&#xD;
      children with congenital heart disease but has been limited to the single ventricle&#xD;
      population in most cases. The benefits of this tool as a standard of care for other children&#xD;
      transitioning home may include decreased readmissions, improved weight gain, and remote&#xD;
      monitoring for reduced throughput in the emergency room, hospital, and clinic settings. To&#xD;
      improve outcomes beyond mortality and into morbidity with other high-risk patients with&#xD;
      congenital heart disease, future studies must assess morbidities and quality of outcomes with&#xD;
      the application of remote home monitoring with applications like the CHAMP app.&#xD;
&#xD;
      Patients that are discharging from the hospital after complex congenital heart disease&#xD;
      surgery and cardiac catheterization are at high risk of events. Adverse outcomes in the year&#xD;
      after discharge are of similar magnitude to mortality in hospital and are not only with&#xD;
      infants with single ventricle heart disease but may include infants and children that were&#xD;
      hospitalized more than 30 days, readmitted to intensive care unit more than once, smaller&#xD;
      size for age, younger age at surgery, shunt dependent for pulmonary blood flow, congenital&#xD;
      heart disease with complexities such as neurological conditions and supplemental enteral&#xD;
      feedings gastrostomy. Over a 6-year period, 6.7% (514/7976) children experienced adverse&#xD;
      events including mortality in a report from England after initial discharge from cardiac&#xD;
      surgery. In a review of our similar patients from Children's Mercy we have noted a 5.8%&#xD;
      mortality in this population.&#xD;
&#xD;
      There is additional focus on expanding transition care in the pediatric cardiac population&#xD;
      beyond 30 days after discharge as traditionally followed by the Society of Thoracic Surgeons&#xD;
      as a marker of well-state (traditionally 8.3%) and onto 90 days (21% of additional&#xD;
      readmissions) to 1 year after discharge. Children had unplanned hospital readmissions during&#xD;
      the first year after cardiac surgery that were between 31 and 90 days after discharge that&#xD;
      could have possibly been prevented with the aid of remote technology in additional to&#xD;
      ambulatory care by a specialized advanced practice nurse. Higher rates of readmissions were&#xD;
      seen with those in lower socioeconomic areas (through zip codes), living closer to the&#xD;
      hospital (potentially a marker of access to care and rurality), higher STAT category, longer&#xD;
      intubation, and longer ICU length of stay were all markers for higher risk of later&#xD;
      readmission after 31 days of discharge.&#xD;
&#xD;
      Combining the advancements with CHAMP app with the expert care teams with advanced practice&#xD;
      nurses, a new standard of care for an expanded group of high-risk infants and children&#xD;
      transitioning home after cardiac surgery and in-hospital care can be established. The&#xD;
      research and ability to improve the understanding of how this process can be applied to an&#xD;
      expanded population that has been identified as high risk is key for implementation and&#xD;
      sustainability of a high risk transition care program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">May 29, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Number of children that had 30 day survival after hospital discharge</measure>
    <time_frame>1 month</time_frame>
    <description>Survival of child after hospital discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of children that had Readmission after initiation hospital discharge</measure>
    <time_frame>2 months</time_frame>
    <description>Hospital readmission after initial discharge</description>
  </primary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Home Monitoring</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Mobile Health</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health Application for Remote Monitoring</intervention_name>
    <description>The use of the CATCH application (CATCH App), and any data and images obtained from the use of the CATCH App, will all be performed as standard of care for patients at Children's Mercy Kansas City, and will be for the clinical treatment of patients. Data will be collected for the repository for all patients submitting data through the use of the CATCH App. Clinical care team will follow the patients after discharge home from the hospital.</description>
    <other_name>CHAMP</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children after hospitalization for heart surgery that required ICU care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Subjects with congenital heart disease that have been hospitalized for more than 30&#xD;
             days,&#xD;
&#xD;
               -  Subjects being discharged with readmissions more than twice to critical care&#xD;
                  areas,&#xD;
&#xD;
               -  Subject with single ventricle physiology that has not been discharged home during&#xD;
                  the single ventricle interstage period,&#xD;
&#xD;
               -  Subjects that are less than 18 years of age,&#xD;
&#xD;
               -  Subjects with gastrostomy or nasogastric tubes and congenital heart disease,&#xD;
&#xD;
               -  Subjects with congenital heart disease who are at a high risk for transition to&#xD;
                  the home setting and are not currently enrolled in the CHAMP single ventricle&#xD;
                  inclusion criteria, and/or&#xD;
&#xD;
               -  Subjects at high risk for events as identified by the Directors of the CATCH app&#xD;
                  Repository.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All patients not meeting at least one of the above specified criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Erickson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</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>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Lushaj EB, Hermsen J, Leverson G, MacLellan-Tobert SG, Nelson K, Amond K, Anagnostopoulos PV. Beyond 30 Days: Analysis of Unplanned Readmissions During the First Year Following Congenital Heart Surgery. World J Pediatr Congenit Heart Surg. 2020 Mar;11(2):177-182. doi: 10.1177/2150135119895212.</citation>
    <PMID>32093562</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>congenital heart disease</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>


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/NCT04498728
org study id: Study00001436
nct id: NCT04498728
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This repository will consist of clinically derived data and images of patients with
      congenital heart disease from the time of birth until they have reached one of the following
      outcomes: transition to outpatient care that has not resulted in readmission in 30 days after
      hospital discharge, death, weaned off supplementary feeding tubes, or clinic visits
      demonstrating clinical stability with their primary cardiologist, or full bi-ventricular
      cardiac surgery palliation with improvement in hemodynamic stability. This information will
      be collected for clinical evaluation and diagnostic purposes and will continue to be stored
      for potential future research application.
Approximately 40,000 infants are born each year with congenital heart disease (CHD), a
      leading cause of morbidity and mortality in infancy. Progress in surgical, transcatheter, and
      medical management of newborn CHD has significantly reduced mortality. The CHAMP app
      (separate IRB # 15030113) has helped to transition high-risk infants with single ventricle
      congenital heart disease out of the hospital and to second stage cardiac surgery at
      Children's Mercy Hospital and across the United States with improved survival. Remote
      monitoring technology and telemedicine is a critical tool to aid clinical care for high risk
      children with congenital heart disease but has been limited to the single ventricle
      population in most cases. The benefits of this tool as a standard of care for other children
      transitioning home may include decreased readmissions, improved weight gain, and remote
      monitoring for reduced throughput in the emergency room, hospital, and clinic settings. To
      improve outcomes beyond mortality and into morbidity with other high-risk patients with
      congenital heart disease, future studies must assess morbidities and quality of outcomes with
      the application of remote home monitoring with applications like the CHAMP app.

      Patients that are discharging from the hospital after complex congenital heart disease
      surgery and cardiac catheterization are at high risk of events. Adverse outcomes in the year
      after discharge are of similar magnitude to mortality in hospital and are not only with
      infants with single ventricle heart disease but may include infants and children that were
      hospitalized more than 30 days, readmitted to intensive care unit more than once, smaller
      size for age, younger age at surgery, shunt dependent for pulmonary blood flow, congenital
      heart disease with complexities such as neurological conditions and supplemental enteral
      feedings gastrostomy. Over a 6-year period, 6.7% (514/7976) children experienced adverse
      events including mortality in a report from England after initial discharge from cardiac
      surgery. In a review of our similar patients from Children's Mercy we have noted a 5.8%
      mortality in this population.

      There is additional focus on expanding transition care in the pediatric cardiac population
      beyond 30 days after discharge as traditionally followed by the Society of Thoracic Surgeons
      as a marker of well-state (traditionally 8.3%) and onto 90 days (21% of additional
      readmissions) to 1 year after discharge. Children had unplanned hospital readmissions during
      the first year after cardiac surgery that were between 31 and 90 days after discharge that
      could have possibly been prevented with the aid of remote technology in additional to
      ambulatory care by a specialized advanced practice nurse. Higher rates of readmissions were
      seen with those in lower socioeconomic areas (through zip codes), living closer to the
      hospital (potentially a marker of access to care and rurality), higher STAT category, longer
      intubation, and longer ICU length of stay were all markers for higher risk of later
      readmission after 31 days of discharge.

      Combining the advancements with CHAMP app with the expert care teams with advanced practice
      nurses, a new standard of care for an expanded group of high-risk infants and children
      transitioning home after cardiac surgery and in-hospital care can be established. The
      research and ability to improve the understanding of how this process can be applied to an
      expanded population that has been identified as high risk is key for implementation and
      sustainability of a high risk transition care program.
observational model: Other
time perspective: Prospective
measure: Number of children that had 30 day survival after hospital discharge
time frame: 1 month
description: Survival of child after hospital discharge
measure: Number of children that had Readmission after initiation hospital discharge
time frame: 2 months
description: Hospital readmission after initial discharge
intervention type: Other
intervention name: Mobile Health Application for Remote Monitoring
description: The use of the CATCH application (CATCH App), and any data and images obtained from the use of the CATCH App, will all be performed as standard of care for patients at Children's Mercy Kansas City, and will be for the clinical treatment of patients. Data will be collected for the repository for all patients submitting data through the use of the CATCH App. Clinical care team will follow the patients after discharge home from the hospital.
other name: CHAMP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lori Erickson, PhD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
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: Lushaj EB, Hermsen J, Leverson G, MacLellan-Tobert SG, Nelson K, Amond K, Anagnostopoulos PV. Beyond 30 Days: Analysis of Unplanned Readmissions During the First Year Following Congenital Heart Surgery. World J Pediatr Congenit Heart Surg. 2020 Mar;11(2):177-182. doi: 10.1177/2150135119895212.
PMID: 32093562
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
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No