NCT06034392

CHAMP App Cardiac Study and Repository

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Lori Erickson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Defects, Congenital
• Pediatrics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-09-13
• Last updated: 2025-12-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study