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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
Endpoints
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 Unless consent is withdrawn, data will be kept and used for data analysis and, if consented to the research repository for multi-site research purposes indefinitely.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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHAMP App | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Human factors/usability engineering: Login failures | Rate of attempts of log-in failures | Over a 3 month period |
| Human factors/usability engineering: Imprecision | Rate of data values reported with imprecision | Over a 3 month period |
| Clinical Safety: Anticipated adverse events | Anticipated Adverse event rates | Over a 3 month period |
| Clinical Safety: Event resolution- anticipated | Time to resolve anticipated adverse events | Time in days, reported over the last 3 months |
| Clinical Safety: Unanticipated Adverse events | Unanticipated adverse event rates | Time in days, reported over the last 3 months |
| Clinical Safety: Event resolution- unanticipated | Time to resolve unanticipated adverse events | Time in days, reported over the last 3 months |
| Health Benefits: Adherence | Rate of adherence to daily data entry | Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period |
| User Satisfaction: Complaints |
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Inclusion Criteria:
Adult participants
Exclusion Criteria:
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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.
Parents who utilize their CHAMP App and the healthcare team that log-in are also part of the CHAMP App study.
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| Name | Affiliation | Role |
|---|---|---|
| Lori Erickson, PhD | Director, Remote Health Solutions Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States | ||
| Nicklaus Variety Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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/CIRCOUTCOMES.115.002452. Epub 2016 May 10. | |
| 29692236 |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Complaint rates via the healthcare team web portal
| Over a 3 month period |
| 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 |
| 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. | through study completion, an average of 9 months |
| 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 |
| CHAMP app performance: Downtime | Product Performance Analytics measured through Any system downtime | Over a 3 month period |
| CHAMP app performance: Cybersecurity | Product Performance Analytics measured through Any reported breaches | Over a 3 month period |
| CHAMP app performance | Product Performance Analytics measured through --Bug/defect rate or Version failure rates | Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required |
| Miami |
| Florida |
| 33155 |
| United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45219 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Cook's Children's | Forth Worth | Texas | 76104 | United States |
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Primary Children's Hospital/University of Utah | Salt Lake City | Utah | 84108 | United States |
| 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. |
| 34365801 | Background | 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. |
| 32662243 | Background | 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. |
| 37421465 | Background | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |