CHAMP App Cardiac Study and Repository

Study Overview
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Brief Summary
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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.

Detailed Description
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Study objectives To evaluate whether data collection and transmission through the CHAMP software platform improves communication between health care providers and parents/LAR that positively affects the care of children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated To determine the accuracy of data obtained regarding observation by parent or caregiver of the condition of children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated. To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction with the data entry, parental self-management, and transmission capabilities. To evaluate the real-world performance analytics (RWPA) of the CHAMP software platform for transfer of parent-entered data for children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated. Endpoints To demonstrate that parents and caregivers for children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated can accurately identify and transmit to healthcare providers specific health-related data including intake of food, fluids and mediations; output, including urination, defecation, and vomiting; weight; vital signs including oxygen saturation as measured by pulse oximetry; heart rate as measured either by a heart rate monitor or manually by the parent or caregiver; and temperature, measured by a reliable thermometer; and the value and reliability of videos provided by parents and caregivers regarding behavior of pediatric study participants for use in evaluating participant's health status. To demonstrate that data obtained through the use of devices such as pulse oximeters, as entered into the app by parents and caregivers, provide valuable information regarding the health status of children with Complex Diagnoses in a home setting. To demonstrate characteristics of CHAMP through real world health analytics (RWHA), user experience analytics (UX), and product performance analytics (PPA). The study duration is open-ended for safety, effectiveness, and performance of the CHAMP app. Unless consent is withdrawn, data will be kept and used for data analysis and, if consented to the research repository for multi-site research purposes indefinitely. At age 18, previously pediatric patients may be approached for reconsent.

Official Title
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CHAMP App Cardiac Study: Evaluation of Software Functions for Asynchronous Monitoring of Children With Complex Congenital Heart Disease in the Home Setting and Data Repository

Conditions
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Heart Defects, Congenital, Pediatrics

Intervention / Treatment
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* Device: CHAMP App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Inability to be discharged to care in the home setting. Those not meeting the above inclusion criteria.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CHAMP App|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human factors/usability engineering: Login failures | Rate of attempts of log-in failures | Over a 3 month period | 
| Human factors/usability engineering: Imprecision | Rate of data values reported with imprecision | Over a 3 month period | 
| Clinical Safety: Anticipated adverse events | Anticipated Adverse event rates | Over a 3 month period | 
| Clinical Safety: Event resolution- anticipated | Time to resolve anticipated adverse events | Time in days, reported over the last 3 months | 
| Clinical Safety: Unanticipated Adverse events | Unanticipated adverse event rates | Time in days, reported over the last 3 months | 
| Clinical Safety: Event resolution- unanticipated | Time to resolve unanticipated adverse events | Time in days, reported over the last 3 months | 
| Health Benefits: Adherence | Rate of adherence to daily data entry | 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 | Complaint rates via the healthcare team web portal | Over a 3 month period | 
| User Satisfaction CHAMP Video | 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. | through study completion, an average of 9 months | 
| User Satisfaction: Communication | 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. | through study completion, an average of 9 months | 
| User Engagement | 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 | Over a 3 month perriod | 
| CHAMP app performance: Downtime | Product Performance Analytics measured through Any system downtime | Over a 3 month period | 
| CHAMP app performance: Cybersecurity | Product Performance Analytics measured through Any reported breaches | Over a 3 month period | 
| CHAMP app performance | Product Performance Analytics measured through --Bug/defect rate or Version failure rates | Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Software Platform