Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-25 @ 11:34 PM
Study NCT ID:
NCT06034392
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-04
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHAMP App Cardiac Study and Repository
Sponsor:
Lori Erickson
Organization:
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMP
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: