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NCT06034392

CHAMP App Cardiac Study and Repository

Enrolling by Invitation
Not specifiedUp to 18Observational
Lori Erickson
~1,000 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:CHAMP App

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Human factors/usability engineering: Login failures
Measured over Over a 3 month period
+13 more outcomes measured

Conditions

Heart Defects, Congenital
Pediatrics

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NCT06034392

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital New Orleans

    New Orleans, Louisianano site contact published

  • Children's Memorial Hermann Hospital

    Houston, Texasno site contact published

  • Children's Mercy Hospital

    Kansas City, Missourino site contact published

  • Children's National Hospital

    Washington D.C., District of Columbiano site contact published

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiono site contact published

  • Cook's Children's

    Forth Worth, Texasno site contact published

  • Nationwide Children's Hospital

    Columbus, Ohiono site contact published

  • Nicklaus Variety Children's Hospital

    Miami, Floridano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lori Erickson, PhD · PRINCIPAL_INVESTIGATOR · Director, Remote Health Solutions Children's Mercy

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.
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.

What this trial measures

  • Human factors/usability engineering: Login failuresOver a 3 month period

    Rate of attempts of log-in failures

  • Human factors/usability engineering: ImprecisionOver a 3 month period

    Rate of data values reported with imprecision

  • Clinical Safety: Anticipated adverse eventsOver a 3 month period

    Anticipated Adverse event rates

  • Clinical Safety: Event resolution- anticipatedTime in days, reported over the last 3 months

    Time to resolve anticipated adverse events

  • Clinical Safety: Unanticipated Adverse eventsTime in days, reported over the last 3 months

    Unanticipated adverse event rates

  • Clinical Safety: Event resolution- unanticipatedTime in days, reported over the last 3 months

    Time to resolve unanticipated adverse events

  • Health Benefits: AdherenceMeasurement 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

  • User Satisfaction: ComplaintsOver a 3 month period

    Complaint rates via the healthcare team web portal

  • User Satisfaction CHAMP Videothrough 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.

  • User Satisfaction: Communicationthrough 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.

  • User EngagementOver 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

  • CHAMP app performance: DowntimeOver a 3 month period

    Product Performance Analytics measured through Any system downtime

  • CHAMP app performance: CybersecurityOver a 3 month period

    Product Performance Analytics measured through Any reported breaches

  • CHAMP app performanceQuarterly 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