CHAMP App Cardiac Study and Repository

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Lori Erickson
Study ID
NCT06034392
Status
Enrolling By Invitation

Conditions

  • Heart Defects, Congenital
  • Pediatrics

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • CHAMP App — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 25, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Human factors/usability engineering: Login failures [ Time Frame: Over a 3 month period ]

Locations (9)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010-
Nicklaus Variety Children's HospitalMiamiFlorida33155-
Children's Hospital New OrleansNew OrleansLouisiana70118-
Children's Mercy HospitalKansas CityMissouri64108-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45219-
Nationwide Children's HospitalColumbusOhio43205-
Cook's Children'sForth WorthTexas76104-
Children's Memorial Hermann HospitalHoustonTexas77030-
Primary Children's Hospital/University of UtahSalt Lake CityUtah84108-

Find similar trials in Washington D.C., DC

By research site
Children's National Hospital· Washington D.C., DCNicklaus Variety Children's Hospital· Miami, FLChildren's Hospital New Orleans· New Orleans, LAChildren's Mercy Hospital· Kansas City, MOCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OH

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