CHAMP App Cardiac Study and Repository

Pediatrics Clinical Trial

— CHAMP  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06034392
• Other study ID #: 15030113CMH
• Status: Enrolling by invitation
• Start date: August 25, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age 0-17 years with a parent/Legally 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. Adult participants
• Parents/Legally 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.

Exclusion Criteria:

• Inability to be discharged to care in the home setting.
• Those not meeting the above inclusion criteria.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Pediatrics

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Nicklaus Variety Children's Hospital	Miami	Florida
United States	Primary Children's Hospital/University of Utah	Salt Lake City	Utah
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Lori Erickson

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human factors/usability engineering: Login failures	Rate of attempts of log-in failures	Over a 3 month period
Primary	Human factors/usability engineering: Imprecision	Rate of data values reported with imprecision	Over a 3 month period
Primary	Clinical Safety: Anticipated adverse events	Anticipated Adverse event rates	Over a 3 month period
Primary	Clinical Safety: Event resolution- anticipated	Time to resolve anticipated adverse events	Time in days, reported over the last 3 months
Primary	Clinical Safety: Unanticipated Adverse events	Unanticipated adverse event rates	Time in days, reported over the last 3 months
Primary	Clinical Safety: Event resolution- unanticipated	Time to resolve unanticipated adverse events	Time in days, reported over the last 3 months
Primary	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
Primary	User Satisfaction: Complaints	Complaint rates via the healthcare team web portal	Over a 3 month period
Primary	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
Primary	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
Primary	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
Primary	CHAMP app performance: Downtime	Product Performance Analytics measured through Any system downtime	Over a 3 month period
Primary	CHAMP app performance: Cybersecurity	Product Performance Analytics measured through Any reported breaches	Over a 3 month period
Primary	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