Clinical trial NCT06034392: CHAMP App Cardiac Study and Repository
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Defects, Congenital
Pediatrics
Keywords: mHealth
Software Platform
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated in the home setting through a multi-regional approach.

Parents who utilize their CHAMP App and the healthcare team that log-in are also part of the CHAMP App study.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Human factors/usability engineering: Login failures
timeFrame: Over a 3 month period
measure: Human factors/usability engineering: Imprecision
timeFrame: Over a 3 month period
measure: Clinical Safety: Anticipated adverse events
timeFrame: Over a 3 month period
measure: Clinical Safety: Event resolution- anticipated
timeFrame: Time in days, reported over the last 3 months
measure: Clinical Safety: Unanticipated Adverse events
timeFrame: Time in days, reported over the last 3 months
measure: Clinical Safety: Event resolution- unanticipated
timeFrame: Time in days, reported over the last 3 months
measure: 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
measure: User Satisfaction: Complaints
timeFrame: Over a 3 month period
measure: User Satisfaction CHAMP Video
timeFrame: through study completion, an average of 9 months
measure: User Satisfaction: Communication
timeFrame: through study completion, an average of 9 months
measure: User Engagement
timeFrame: Over a 3 month perriod
measure: CHAMP app performance: Downtime
timeFrame: Over a 3 month period
measure: CHAMP app performance: Cybersecurity
timeFrame: Over a 3 month period
measure: CHAMP app performance
timeFrame: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Miami
country: United States
facility: Nicklaus Variety Children's Hospital
state: Florida
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Forth Worth
country: United States
facility: Cook's Children's
state: Texas
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital/University of Utah
state: Utah
Study officials:
affiliation: Director, Remote Health Solutions Children's Mercy
name: Lori Erickson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shirali G, Erickson L, Apperson J, Goggin K, Williams D, Reid K, Bradley-Ewing A, Tucker D, Bingler M, Spertus J, Rabbitt L, Stroup R. Harnessing Teams and Technology to Improve Outcomes in Infants With Single Ventricle. Circ Cardiovasc Qual Outcomes. 2016 May;9(3):303-11. doi: 10.1161/CIRCOUTCOMES.115.002452. Epub 2016 May 10.
citation: Bingler M, Erickson LA, Reid KJ, Lee B, O'Brien J, Apperson J, Goggin K, Shirali G. Interstage Outcomes in Infants With Single Ventricle Heart Disease Comparing Home Monitoring Technology to Three-Ring Binder Documentation: A Randomized Crossover Study. World J Pediatr Congenit Heart Surg. 2018 May;9(3):305-314. doi: 10.1177/2150135118762401.
citation: Aly DM, Erickson LA, Hancock H, Apperson JW, Gaddis M, Shirali G, Goudar S. Ability of Video Telemetry to Predict Unplanned Hospital Admissions for Single Ventricle Infants. J Am Heart Assoc. 2021 Aug 17;10(16):e020851. doi: 10.1161/JAHA.121.020851. Epub 2021 Aug 7.
citation: Erickson LA, Emerson A, Russell CL. Parental mobile health adherence to symptom home monitoring for infants with congenital heart disease during the single ventricle interstage period: A concept analysis. J Spec Pediatr Nurs. 2020 Oct;25(4):e12303. doi: 10.1111/jspn.12303. Epub 2020 Jul 14.
citation: Patel PS, Shah SK, Feldman K, Hancock HS, Moehlmann ML, Ricketts A, Files MD, McFarland C, Erickson L, Romans RA. Associations of Home Monitoring Data to Interventional Catheterization for Infants with Recurrent Coarctation of the Aorta and Hypoplastic Left Heart Syndrome. Pediatr Cardiol. 2023 Oct;44(7):1462-1470. doi: 10.1007/s00246-023-03224-8. Epub 2023 Jul 8.