CHAMP App Cardiac Study and Repository

NCT06034392 | Enrolling By Invitation FDA Device

• 1 other identifier: 15030113CMH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Heart Defects, Congenital; Pediatrics

Keywords

mHealth; Software Platform

Outcome Measures

Primary Outcomes (14)

• 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

  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

Interventions

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to be discharged to care in the home setting.

Sponsors & Collaborators

• Lori Erickson: lead

Study Sites (9)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Nicklaus Variety Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45219, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Cook's Children's

Forth Worth, Texas, 76104, United States

Location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Primary Children's Hospital/University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 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.

  PMID: 34365801 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.

  PMID: 32662243 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.

  PMID: 37421465 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lori Erickson, PhD

  Director, Remote Health Solutions Children's Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Remote Health Solutions

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 13, 2023
• Study Start: August 25, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

US (9)