CHAMP App Cardiac Study and Repository (CHAMP)

May 1, 2026 updated by: Lori Erickson

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Device: CHAMP App

Detailed Description

Study objectives

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
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.
To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction with the data entry, parental self-management, and transmission capabilities.
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

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.
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.
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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Children's National Hospital
- Florida
  - Miami, Florida, United States, 33155
    - Nicklaus Variety Children's Hospital
- Louisiana
  - New Orleans, Louisiana, United States, 70118
    - Children's Hospital New Orleans
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Children's Mercy Hospital
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Cincinnati Children's Hospital Medical Center
  - Columbus, Ohio, United States, 43205
    - Nationwide Children's Hospital
- Texas
  - Forth Worth, Texas, United States, 76104
    - Cook's Children's
  - Houston, Texas, United States, 77030
    - Children's Memorial Hermann Hospital
- Utah
  - Salt Lake City, Utah, United States, 84108
    - Primary Children's Hospital/University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human factors/usability engineering: Login failures Time Frame: Over a 3 month period	Rate of attempts of log-in failures	Over a 3 month period
Human factors/usability engineering: Imprecision Time Frame: Over a 3 month period	Rate of data values reported with imprecision	Over a 3 month period
Clinical Safety: Anticipated adverse events Time Frame: Over a 3 month period	Anticipated Adverse event rates	Over a 3 month period
Clinical Safety: Event resolution- anticipated Time Frame: Time in days, reported over the last 3 months	Time to resolve anticipated adverse events	Time in days, reported over the last 3 months
Clinical Safety: Unanticipated Adverse events Time Frame: Time in days, reported over the last 3 months	Unanticipated adverse event rates	Time in days, reported over the last 3 months
Clinical Safety: Event resolution- unanticipated Time Frame: Time in days, reported over the last 3 months	Time to resolve unanticipated adverse events	Time in days, reported over the last 3 months
Health Benefits: Adherence Time Frame: Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period	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 Time Frame: Over a 3 month period	Complaint rates via the healthcare team web portal	Over a 3 month period
CHAMP app performance: Downtime Time Frame: Over a 3 month period	Product Performance Analytics measured through Any system downtime	Over a 3 month period
CHAMP app performance: Cybersecurity Time Frame: Over a 3 month period	Product Performance Analytics measured through Any reported breaches	Over a 3 month period
CHAMP app performance Time Frame: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required	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
User Satisfaction CHAMP Video Time Frame: through study completion, an average of 9 months	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 Time Frame: through study completion, an average of 9 months	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 Time Frame: Over a 3 month perriod	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research Repository Time Frame: Ongoing	Remote Patient Monitoring Research Repository	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lori Erickson

Investigators

Principal Investigator: Lori Erickson, PhD, Director, Remote Health Solutions Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified