CHAMP App for Medically Complex Children

(PARAMETER Trial)

Overseen By Ryan Thompson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Cardiac program, PICC lines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new mobile app, the CHAMP App, can reduce hospital readmissions and improve the experience of parents with medically complex children. The app enables parents to enter daily home monitoring data, such as feeding, oxygen levels, and heart rate, which the healthcare team reviews to provide timely support. The trial includes two groups: one uses the app with proactive monitoring from nurses, while the other follows standard care with manual data logging. Families with children under 4 years old who use medical devices at home might find this trial suitable. As an unphased trial, this study offers families the chance to contribute to innovative healthcare solutions that could enhance daily life and care for their children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the CHAMP App is safe for medically complex children?

Research shows that the CHAMP App is generally easy for users to handle. In past studies, more than 100 children aged 4-8 used the app, which assists children with serious heart conditions. These studies did not find any major safety problems.

The app tracks health information, such as heart rate and oxygen levels, at home. It has proven effective in helping children with single-ventricle heart defects by providing important information to doctors.

No reports of negative effects from using the app have emerged, suggesting that it is safe for children when used as part of a health monitoring program. However, as with any new technology, research continues to ensure it remains safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHAMP App because it represents a proactive approach to managing medically complex children's health care. Unlike traditional methods that rely on parents to manually track and report data, the CHAMP App facilitates continuous data monitoring with real-time communication between parents and healthcare providers. This method allows for timely interventions based on comprehensive and up-to-date information. By using a mobile application, the CHAMP App enhances the coordination of care and potentially improves health outcomes for these vulnerable patients.

What evidence suggests that the CHAMP App is effective for reducing 30-day all-cause readmission rates in medically complex children?

This trial will compare the use of the CHAMP App with standard care for children with complex medical needs. Research has shown that the CHAMP App, used by participants in one arm of this trial, can enhance care by enabling parents to track important health information daily at home. Nurse coordinators then review this data, potentially improving communication between healthcare providers and parents. By closely monitoring factors like feeding and heart rate, the app aims to reduce hospital readmissions. Although large trials have not yet provided extensive data, this method relies on proven strategies to better manage complex health conditions in children. ^{6 7 8 9 10}

Who Is on the Research Team?

Lori Erickson, PhD

Principal Investigator

Children's Mercy Kansas City

Are You a Good Fit for This Trial?

This trial is for children aged 0-3 years with complex medical conditions who are discharging to a home setting. Parents or legal representatives must be able to read English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic or Vietnamese and download an app.

Inclusion Criteria

Adult Group 2: Healthcare team users at Children's Mercy Kansas City

I am under 4 years old and have a guardian.

I will be discharged to a home where caregivers understand English, Spanish, Somali, Burmese, Korean, Chinese-Simplified, German, French, Filipino, Arabic, or Vietnamese.

Exclusion Criteria

Not meeting the above inclusion criteria

Child followed solely by the Cardiac High Acuity Monitoring Program Heart Center outpatient team

Parent/LAR that do not speak or read one of the 11 languages available in the CHAMP application

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a mobile health application for remote patient monitoring and communication with healthcare providers

30 days

Weekly data monitoring by clinical nurse coordinators

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHAMP App

Trial Overview The CHAMP mobile application's effectiveness in reducing hospital readmission rates and improving parent experience is being tested. The study randomly assigns participants into two groups to compare outcomes within a month after discharge.

How Is the Trial Designed?

Group I: Proactive Nursing Care model using a mobile application and software platform Experimental Treatment 1 Intervention

* Includes weekly data monitoring by the study team clinical nurse coordinators with communication through phone, email, or patient portal with documentation in the EMR * Email delivery of data summary reports on each child's data to their outpatient providers, Unrestricted research team approved healthcare team provider access to this data through the CHAMP App PARAMETER web portal, * Follow-up communications from providers to parents at provider discretion, and initiation of Health interventions by providers as deemed clinically appropriate from their review of the data collected and their knowledge of the participant. * Parents will enter home monitoring data daily into the CHAMP App as fitting with their discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these.

Group II: Standard of care control arm Active Control 1 Intervention

* No proactive monitoring or communication from the research coordinators * Follow-up communications from providers to parents at their general healthcare providers discretion, and Initiation of health interventions by providers as deemed clinically appropriate from their review of the data collected and reported by parents via patient portal, phone, and in-person communications and their knowledge of the participant. * Parents will be provided a paper log that they will utilize for recording their child's home monitoring data and turn in at the end of the month * Parents will write down the home monitoring data fitting with their child's discharge regimen: This may include Feeding, oxygen saturation, heart rate, videos, weight (home scale), or a combination of these. * Optional: Parents can utilize the App if they allocate to Arm 2 (Paper) at first, with a combined weekly check-in with the research coordinators. The parents will get a chance to fill out SUS after month of use

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Citations

1. uvm.edu uvm.edu/larnermed/vchip/child-health-advances-measured-practice-champ

Child Health Advances Measured in Practice (CHAMP) CHAMP's long-term goal is to increase the efficiency, economy, and quality of care provided to Medicaid-eligible children and families. Building on the ...

2. aap.org aap.org/en/patient-care/children-with-medical-complexity/?srsltid=AfmBOooI-Tkl7n9Qf7R50FwtfRfnZzbgRaFEwIRMGcr6WmXob5e5NWLl

Children with Medical Complexity Discover guidance and resources to support pediatricians and health care teams caring for children with medical complexity.

3. researchprotocols.org researchprotocols.org/2024/1/e60621

Effectiveness of a Mobile App (Meds@HOME) to Improve ... This study will pilot-test the mobile app, Medication Safety @HOME—Meds@HOME intervention to improve medication administration accuracy ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705626/

The ChAMP App: A Scalable mHealth Technology for ... As proof of principle, we present ChAMP System data from 101 children 4–8 years old, with and without diagnosed mental health disorders. Machine learning models ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10028546/

Effectiveness of Structured Care Coordination for Children ... Effectiveness of structured care coordination for children with medical complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11133764/

The ChAMP App: A Scalable mHealth Technology for ... As proof of principle, we present ChAMP System data from 101 children 4–8 years old, with and without diagnosed mental health disorders. Machine learning models ...

7. transformpeds.childrensmercy.org transformpeds.childrensmercy.org/expanding-the-reach-of-champ-for-single-ventricle--patients/

Expanding the Reach of CHAMP for Single-Ventricle Patients The Cardiac High Acuity Monitoring Program (CHAMP) has been improving outcomes for patients with single-ventricle heart defects during the period between their ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06129877

NCT06129877 | CHAMP App Feeding Difficulties Repository This repository will consist of home monitoring data, videos, and images of patients with feeding difficulties for asynchronous remote patient monitoring of ...

9. researchgate.net researchgate.net/publication/376044490_The_ChAMP_App_A_Scalable_mHealth_Technology_for_Detecting_Digital_Phenotypes_of_Early_Childhood_Mental_Health

(PDF) The ChAMP App: A Scalable mHealth Technology ... As proof of principle, we present ChAMP System data from 101 children 4-8 years old, with and without diagnosed mental health disorders. Machine ...

10. youtube.com youtube.com/watch?v=gwHZA-GbIE0

CHAMP app saves babies lives Doctors at Children's Mercy Hospital are using the cloud to help infants survive a dangerous congenital heart condition called HLHS.