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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

Explore related trials

Congenital Heart Disease

Where it's being run

9 sites across 7 states
Ohio2
Texas2
District of Columbia1
Florida1
Louisiana1
Missouri1
Utah1

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

Do you actually qualify for this trial?

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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