Status:
ENROLLING_BY_INVITATION
CHAMP App Cardiac Study and Repository
Lead Sponsor:
Lori Erickson
Conditions:
Heart Defects, Congenital
Pediatrics
Eligibility:
All Genders
Up to 18 years
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 heal...
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 affec...
Eligibility Criteria
Inclusion
- 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
- Inability to be discharged to care in the home setting.
- Those not meeting the above inclusion criteria.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06034392
Start Date
August 25 2023
End Date
December 31 2026
Last Update
December 4 2025
Active Locations (9)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
2
Nicklaus Variety Children's Hospital
Miami, Florida, United States, 33155
3
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
4
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108