Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06034392

CHAMP App Cardiac Study and Repository

Sponsor: Lori Erickson

View on ClinicalTrials.gov

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

Interventions

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 (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