Heart Defects, CongenitalCHAMPNCT06034392
CHAMP App Cardiac Study and Repository
An observational study of Heart Defects, Congenital and Pediatrics, run by Lori Erickson at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Defects, Congenital, Pediatrics
- What is being tested?
- CHAMP App
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Aug 2023to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to be discharged to care in the home setting.
- Those not meeting the above inclusion criteria.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45219
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cook's Children's
Forth Worth, Texas, 76104
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Children's Mercy Hospital
Kansas City, Missouri, 64108
Nicklaus Variety Children's Hospital
Miami, Florida, 33155
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Primary Children's Hospital/University of Utah
Salt Lake City, Utah, 84108
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
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
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.
Read the detailed description
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.
- Conditions
- Heart Defects, Congenital, Pediatrics
- Being tested
- CHAMP App
- Keywords
- mHealth, Software Platform
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAMP AppDevice
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 being measured
The primary outcome is the main question the study is designed to answer.
Human factors/usability engineering: Login failures
Rate of attempts of log-in failures
Measured: Over a 3 month period
Human factors/usability engineering: Imprecision
Rate of data values reported with imprecision
Measured: Over a 3 month period
Clinical Safety: Anticipated adverse events
Anticipated Adverse event rates
Measured: Over a 3 month period
Clinical Safety: Event resolution- anticipated
Time to resolve anticipated adverse events
Measured: Time in days, reported over the last 3 months
Clinical Safety: Unanticipated Adverse events
Unanticipated adverse event rates
Measured: Time in days, reported over the last 3 months
Clinical Safety: Event resolution- unanticipated
Time to resolve unanticipated adverse events
Measured: Time in days, reported over the last 3 months
Health Benefits: Adherence
Rate of adherence to daily data entry
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Over a 3 month perriod
CHAMP app performance: Downtime
Product Performance Analytics measured through Any system downtime
Measured: Over a 3 month period
CHAMP app performance: Cybersecurity
Product Performance Analytics measured through Any reported breaches
Measured: Over a 3 month period
CHAMP app performance
Product Performance Analytics measured through --Bug/defect rate or Version failure rates
Measured: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Lori Erickson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lori Erickson, Children's Mercy Hospital Kansas City
- Investigators
- Lori Erickson, PhD, Principal investigator, Director, Remote Health Solutions Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034392
- Sponsor's protocol ID
- 15030113CMH
- Acronym
- CHAMP
- Status last verified
- May 2026
- First submitted
- 24 Aug 2023
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27166202Bingler 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.
PubMed 29692236Aly 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.
PubMed 34365801Erickson 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.
PubMed 32662243Patel 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.
PubMed 37421465
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06034392
- Acronym / sponsor ID
- CHAMP / 15030113CMH
- Conditions
- Heart Defects, Congenital, Pediatrics
- Keywords
- mHealth, Software Platform
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lori EricksonUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to be discharged to care in the home setting.
- Those not meeting the above inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHAMP AppCHAMP® 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. | Device | – |
Primary outcome
Human factors/usability engineering: Login failures
Time frame: Over a 3 month period
Rate of attempts of log-in failures
Human factors/usability engineering: Imprecision
Time frame: Over a 3 month period
Rate of data values reported with imprecision
Clinical Safety: Anticipated adverse events
Time frame: Over a 3 month period
Anticipated Adverse event rates
Clinical Safety: Event resolution- anticipated
Time frame: Time in days, reported over the last 3 months
Time to resolve anticipated adverse events
Clinical Safety: Unanticipated Adverse events
Time frame: Time in days, reported over the last 3 months
Unanticipated adverse event rates
Clinical Safety: Event resolution- unanticipated
Time frame: Time in days, reported over the last 3 months
Time to resolve unanticipated adverse events
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
User Satisfaction: Complaints
Time frame: Over a 3 month period
Complaint rates via the healthcare team web portal
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.
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.
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
CHAMP app performance: Downtime
Time frame: Over a 3 month period
Product Performance Analytics measured through Any system downtime
CHAMP app performance: Cybersecurity
Time frame: Over a 3 month period
Product Performance Analytics measured through Any reported breaches
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 27166202Shirali 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.
- Background: PubMed 29692236Bingler 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.
- Background: PubMed 34365801Aly 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.
- Background: PubMed 32662243Erickson 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.
- Background: PubMed 37421465Patel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Erickson, PhD principal investigator
Director, Remote Health Solutions Children's Mercy
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital and Pediatrics, run by Lori Erickson at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human factors/usability engineering: Login failures (time frame: Over a 3 month period). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034392, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.