CHAMP App for Medically Complex Children
(PARAMETER Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use a mobile health application for remote patient monitoring and communication with healthcare providers
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
* 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.
* 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
Citations
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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 ...
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 ...
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.
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