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.
Study objectives 1. 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 2. 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. 3. To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction with the data entry, parental self-management, and transmission capabilities. 4. 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 1. 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. 2. 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. 3. 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.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
Children's National Hospital
Washington D.C., District of Columbia, United States
Nicklaus Variety Children's Hospital
Miami, Florida, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Human factors/usability engineering: Login failures
Rate of attempts of log-in failures
Time frame: Over a 3 month period
Human factors/usability engineering: Imprecision
Rate of data values reported with imprecision
Time frame: Over a 3 month period
Clinical Safety: Anticipated adverse events
Anticipated Adverse event rates
Time frame: Over a 3 month period
Clinical Safety: Event resolution- anticipated
Time to resolve anticipated adverse events
Time frame: Time in days, reported over the last 3 months
Clinical Safety: Unanticipated Adverse events
Unanticipated adverse event rates
Time frame: Time in days, reported over the last 3 months
Clinical Safety: Event resolution- unanticipated
Time to resolve unanticipated adverse events
Time frame: Time in days, reported over the last 3 months
Health Benefits: Adherence
Rate of adherence to daily data entry
Time frame: 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
Time frame: Over a 3 month period
User Satisfaction CHAMP Video
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Mercy Hospital
Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Cook's Children's
Forth Worth, Texas, United States
Children's Memorial Hermann Hospital
Houston, Texas, United States
Primary Children's Hospital/University of Utah
Salt Lake City, Utah, United States
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.
Time frame: 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.
Time frame: 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
Time frame: Over a 3 month perriod
CHAMP app performance: Downtime
Product Performance Analytics measured through Any system downtime
Time frame: Over a 3 month period
CHAMP app performance: Cybersecurity
Product Performance Analytics measured through Any reported breaches
Time frame: Over a 3 month period
CHAMP app performance
Product Performance Analytics measured through --Bug/defect rate or Version failure rates
Time frame: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required