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Enrolling by Invitation

NCT Number: NCT06034392

CHAMP App Cardiac Study and Repository

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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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases Pediatrics

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Hospital, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHAMP App

Device

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.

Primary outcomes

  1. Human factors/usability engineering: Login failures

    Time frame: Over a 3 month period

    Rate of attempts of log-in failures

  2. Human factors/usability engineering: Imprecision

    Time frame: Over a 3 month period

    Rate of data values reported with imprecision

  3. Clinical Safety: Anticipated adverse events

    Time frame: Over a 3 month period

    Anticipated Adverse event rates

  4. Clinical Safety: Event resolution- anticipated

    Time frame: Time in days, reported over the last 3 months

    Time to resolve anticipated adverse events

  5. Clinical Safety: Unanticipated Adverse events

    Time frame: Time in days, reported over the last 3 months

    Unanticipated adverse event rates

  6. Clinical Safety: Event resolution- unanticipated

    Time frame: Time in days, reported over the last 3 months

    Time to resolve unanticipated adverse events

  7. Health Benefits: Adherence

    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

    Rate of adherence to daily data entry

  8. User Satisfaction: Complaints

    Time frame: Over a 3 month period

    Complaint rates via the healthcare team web portal

  9. User Satisfaction CHAMP Video

    Time frame: through 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.

  10. User Satisfaction: Communication

    Time frame: through 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.

  11. User Engagement

    Time frame: Over 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

  12. CHAMP app performance: Downtime

    Time frame: Over a 3 month period

    Product Performance Analytics measured through Any system downtime

  13. CHAMP app performance: Cybersecurity

    Time frame: Over a 3 month period

    Product Performance Analytics measured through Any reported breaches

  14. CHAMP app performance

    Time frame: Quarterly 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

Sponsors and collaborators

Lead sponsor

Lori Erickson

Other

Registry information

Official study 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

Acronym: CHAMP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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