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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Human factors/usability engineering: Login failures
Timeframe: Over a 3 month period
Human factors/usability engineering: Imprecision
Timeframe: Over a 3 month period
Clinical Safety: Anticipated adverse events
Timeframe: Over a 3 month period
Clinical Safety: Event resolution- anticipated
Timeframe: Time in days, reported over the last 3 months
Clinical Safety: Unanticipated Adverse events
Timeframe: Time in days, reported over the last 3 months
Clinical Safety: Event resolution- unanticipated
Timeframe: Time in days, reported over the last 3 months
Health Benefits: Adherence
Timeframe: Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period
User Satisfaction: Complaints
Timeframe: Over a 3 month period
User Satisfaction CHAMP Video
Timeframe: through study completion, an average of 9 months
User Satisfaction: Communication
Timeframe: through study completion, an average of 9 months
User Engagement
Timeframe: Over a 3 month perriod
CHAMP app performance: Downtime
Timeframe: Over a 3 month period
CHAMP app performance: Cybersecurity
Timeframe: Over a 3 month period
CHAMP app performance
Timeframe: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required