Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-10 @ 11:07 AM
Study NCT ID:
NCT06034392
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-04
First Post:
2023-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHAMP App Cardiac Study and Repository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Human factors/usability engineering: Login failures', 'timeFrame': 'Over a 3 month period', 'description': 'Rate of attempts of log-in failures'}, {'measure': 'Human factors/usability engineering: Imprecision', 'timeFrame': 'Over a 3 month period', 'description': 'Rate of data values reported with imprecision'}, {'measure': 'Clinical Safety: Anticipated adverse events', 'timeFrame': 'Over a 3 month period', 'description': 'Anticipated Adverse event rates'}, {'measure': 'Clinical Safety: Event resolution- anticipated', 'timeFrame': 'Time in days, reported over the last 3 months', 'description': 'Time to resolve anticipated adverse events'}, {'measure': 'Clinical Safety: Unanticipated Adverse events', 'timeFrame': 'Time in days, reported over the last 3 months', 'description': 'Unanticipated adverse event rates'}, {'measure': 'Clinical Safety: Event resolution- unanticipated', 'timeFrame': 'Time in days, reported over the last 3 months', 'description': 'Time to resolve unanticipated adverse events'}, {'measure': 'Health Benefits: Adherence', 'timeFrame': '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', 'timeFrame': 'Over a 3 month period', 'description': 'Complaint rates via the healthcare team web portal'}, {'measure': 'User Satisfaction CHAMP Video', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': 'Over a 3 month period', 'description': 'Product Performance Analytics measured through Any system downtime'}, {'measure': 'CHAMP app performance: Cybersecurity', 'timeFrame': 'Over a 3 month period', 'description': 'Product Performance Analytics measured through Any reported breaches'}, {'measure': 'CHAMP app performance', 'timeFrame': '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'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['mHealth', 'Software Platform'], 'conditions': ['Heart Defects, Congenital', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '27166202', 'type': 'BACKGROUND', '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': '29692236', 'type': 'BACKGROUND', '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': '34365801', 'type': 'BACKGROUND', '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': '32662243', 'type': 'BACKGROUND', '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': '37421465', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Study objectives\n\n1. 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\n2. 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.\n3. To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction with the data entry, parental self-management, and transmission capabilities.\n4. 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.\n\nEndpoints\n\n1. 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.\n2. 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.\n3. To demonstrate characteristics of CHAMP through real world health analytics (RWHA), user experience analytics (UX), and product performance analytics (PPA).\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated in the home setting through a multi-regional approach.\n\nParents who utilize their CHAMP App and the healthcare team that log-in are also part of the CHAMP App study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 0-17 years with a parent/Legally authorized representative\n* Diagnosed with a complex health condition in which asynchronous monitoring in the home setting is appropriate.\n* Pediatric patient's cardiac care team has decided that the patient's treatment plan may benefit from remote home monitoring.\n* Institution that the subject is followed through clinically has been an approved as site for the CHAMP app study with Children's Mercy Kansas City.\n\nAdult participants\n\n* Parents/Legally authorized representatives of pediatric subject.\n* Healthcare team users at an institution that is an approved site for the CHAMP app Study with Children's Mercy Kansas City.\n\nExclusion Criteria:\n\n* Inability to be discharged to care in the home setting.\n* Those not meeting the above inclusion criteria."}, 'identificationModule': {'nctId': 'NCT06034392', 'acronym': 'CHAMP', 'briefTitle': 'CHAMP App Cardiac Study and Repository', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '15030113CMH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CHAMP App', 'type': 'DEVICE', '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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Variety Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '76104', 'city': 'Forth Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook's Children's"}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital/University of Utah", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Lori Erickson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Director, Remote Health Solutions Children's Mercy"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lori Erickson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Remote Health Solutions', 'investigatorFullName': 'Lori Erickson', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}