[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06034392":3,"trial-entities:NCT06034392":194,"trial-summary:NCT06034392":198},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":15,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":34,"secondary_outcomes":83,"sex":84,"minimum_age":15,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":98,"locations":101,"central_contacts":170,"overall_officials":171,"references":176,"see_also_links":193},"NCT06034392","15030113CMH","CHAMP App Cardiac Study and Repository","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","ENROLLING_BY_INVITATION","2026-12-31","2026-05","2026-05-07","2023-08-25","Lori Erickson","OTHER",null,"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\u002For uploaded by the parent or other legally authorized representative (LAR) of patients with complex congenital heart disease as a target population.","Study objectives\n\n1. To evaluate whether data collection and transmission through the CHAMP software platform improves communication between health care providers and parents\u002FLAR 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.",[19,20],"Heart Defects, Congenital","Pediatrics",[22,23],"mHealth","Software Platform","OBSERVATIONAL",[],{"count":27,"type":28},1000,"ESTIMATED",[30],{"type":31,"name":32,"description":33},"DEVICE","CHAMP App","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.",[35,39,42,45,49,52,55,59,62,66,69,73,76,79],{"measure":36,"description":37,"timeFrame":38},"Human factors\u002Fusability engineering: Login failures","Rate of attempts of log-in failures","Over a 3 month period",{"measure":40,"description":41,"timeFrame":38},"Human factors\u002Fusability engineering: Imprecision","Rate of data values reported with imprecision",{"measure":43,"description":44,"timeFrame":38},"Clinical Safety: Anticipated adverse events","Anticipated Adverse event rates",{"measure":46,"description":47,"timeFrame":48},"Clinical Safety: Event resolution- anticipated","Time to resolve anticipated adverse events","Time in days, reported over the last 3 months",{"measure":50,"description":51,"timeFrame":48},"Clinical Safety: Unanticipated Adverse events","Unanticipated adverse event rates",{"measure":53,"description":54,"timeFrame":48},"Clinical Safety: Event resolution- unanticipated","Time to resolve unanticipated adverse events",{"measure":56,"description":57,"timeFrame":58},"Health Benefits: Adherence","Rate of adherence to daily data entry","Measurement of adherence to daily data entry per each patient\u002Fparent over 3 month period on non-hospitalized days, during the study period",{"measure":60,"description":61,"timeFrame":38},"User Satisfaction: Complaints","Complaint rates via the healthcare team web portal",{"measure":63,"description":64,"timeFrame":65},"User Satisfaction CHAMP Video","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.","through study completion, an average of 9 months",{"measure":67,"description":68,"timeFrame":65},"User Satisfaction: Communication","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":70,"description":71,"timeFrame":72},"User Engagement","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","Over a 3 month perriod",{"measure":74,"description":75,"timeFrame":38},"CHAMP app performance: Downtime","Product Performance Analytics measured through Any system downtime",{"measure":77,"description":78,"timeFrame":38},"CHAMP app performance: Cybersecurity","Product Performance Analytics measured through Any reported breaches",{"measure":80,"description":81,"timeFrame":82},"CHAMP app performance","Product Performance Analytics measured through --Bug\u002Fdefect rate or Version failure rates","Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required",[],"ALL","18 Years",false,{"inclusion":88,"exclusion":95,"raw_text":97},[89,90,91,92,93,94],"Age 0-17 years with a parent\u002FLegally authorized representative","Diagnosed with a complex health condition in which asynchronous monitoring in the home setting is appropriate.","Pediatric patient's cardiac care team has decided that the patient's treatment plan may benefit from remote home monitoring.","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.","Parents\u002FLegally authorized representatives of pediatric subject.","Healthcare team users at an institution that is an approved site for the CHAMP app Study with Children's Mercy Kansas City.",[96],"Inability to be discharged to care in the home setting.","Inclusion Criteria:\n\n* Age 0-17 years with a parent\u002FLegally 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\u002FLegally 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.",[99,100],"CHILD","ADULT",[102,111,119,127,135,143,150,155,162],{"facility":103,"city":104,"state":105,"zip":106,"country":107,"geoPoint":108},"Children's National Hospital","Washington D.C.","District of Columbia","20010","United States",{"lat":109,"lon":110},38.89511,-77.03637,{"facility":112,"city":113,"state":114,"zip":115,"country":107,"geoPoint":116},"Nicklaus Variety Children's Hospital","Miami","Florida","33155",{"lat":117,"lon":118},25.77427,-80.19366,{"facility":120,"city":121,"state":122,"zip":123,"country":107,"geoPoint":124},"Children's Hospital New Orleans","New Orleans","Louisiana","70118",{"lat":125,"lon":126},29.95465,-90.07507,{"facility":128,"city":129,"state":130,"zip":131,"country":107,"geoPoint":132},"Children's Mercy Hospital","Kansas City","Missouri","64108",{"lat":133,"lon":134},39.09973,-94.57857,{"facility":136,"city":137,"state":138,"zip":139,"country":107,"geoPoint":140},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45219",{"lat":141,"lon":142},39.12711,-84.51439,{"facility":144,"city":145,"state":138,"zip":146,"country":107,"geoPoint":147},"Nationwide Children's Hospital","Columbus","43205",{"lat":148,"lon":149},39.96118,-82.99879,{"facility":151,"city":152,"state":153,"zip":154,"country":107},"Cook's Children's","Forth Worth","Texas","76104",{"facility":156,"city":157,"state":153,"zip":158,"country":107,"geoPoint":159},"Children's Memorial Hermann Hospital","Houston","77030",{"lat":160,"lon":161},29.76328,-95.36327,{"facility":163,"city":164,"state":165,"zip":166,"country":107,"geoPoint":167},"Primary Children's Hospital\u002FUniversity of Utah","Salt Lake City","Utah","84108",{"lat":168,"lon":169},40.76078,-111.89105,[],[172],{"name":173,"affiliation":174,"role":175},"Lori Erickson, PhD","Director, Remote Health Solutions Children's Mercy","PRINCIPAL_INVESTIGATOR",[177,181,184,187,190],{"pmid":178,"type":179,"citation":180},"27166202","BACKGROUND","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\u002FCIRCOUTCOMES.115.002452. Epub 2016 May 10.",{"pmid":182,"type":179,"citation":183},"29692236","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\u002F2150135118762401.",{"pmid":185,"type":179,"citation":186},"34365801","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\u002FJAHA.121.020851. Epub 2021 Aug 7.",{"pmid":188,"type":179,"citation":189},"32662243","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\u002Fjspn.12303. Epub 2020 Jul 14.",{"pmid":191,"type":179,"citation":192},"37421465","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\u002Fs00246-023-03224-8. Epub 2023 Jul 8.",[],{"nct_id":4,"conditions":195,"biomarkers":197},[196],"Congenital Heart Disease",[],{"nct_id":4,"found":86,"summary":15,"prompt_version":15}]