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CHAMP App Cardiac Study and Repository
Sponsor: Lori Erickson
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.
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
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-08-25
Completion Date
2026-12-31
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
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 (9)
Children's National Hospital
Washington D.C., District of Columbia, United States
Nicklaus Variety Children's Hospital
Miami, Florida, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Cook's Children's
Forth Worth, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
Primary Children's Hospital/University of Utah
Salt Lake City, Utah, United States