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 manually entered data sent by parents to the healthcare team using the CHAMP App for children with feeding difficulties. This information will be collected under a research protocol and this repository is for future research applications.

Study Overview

• Status: Enrolling by invitation
• Conditions: Feeding and Eating Disorders of Childhood; Gastrostomy; Feeding Disorder of Infancy and Childhood
• Intervention / Treatment: Device: CHAMP App

Detailed Description

Around 25% of children are reported to have some degree of feeding issues of whom 3-10% have more severe feeding disorders1. Many of these feeding issues and difficulties can also lead to a need for supplemental nutrition in a child's diet due to the impact on growth. Those requiring supplemental nutrition may find themselves having to be fed using tube feedings (TF), which carries its own set of obstacles and factors to consider. While feeding problems have been estimated to occur in 25%-35% of children observed as exhibiting normal growth, that number may spike to 85% in those with GI-related growth disorders2. This highlights the need to ensure treatment plans and programs are in place to assist this patient population.

At Children's Mercy Hospital, GI specialists care for children who have a variety of conditions, caring for the whole child and addressing physical, mental, emotional, and social aspects. By using a combined approach, and promoting research that seeks to improve care, significant improvements in children's health have been reported. One specialty this has been evident in at Children's Mercy is the cardiac patient population. There have been improvements in growth, feedings, and timeliness of interventions seen with the use of CHAMP® App in the single ventricle population (a statistically significant difference in the frequency of growth failure, with no patients having growth failure during CHAMP use)3-4. By harnessing the experience and knowledge gained through the CHAMP® App research study, there is a great potential for children suffering from GI conditions to also benefit from this form of remote patient management and monitoring, especially when it comes to treating children with supplemental nutrition needs. There are no known Gastroenterology- Feeding mobile health software platforms with a dedicated research repository in pediatrics.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with feeding difficulties and/or malnutrition

Description

Inclusion Criteria:

• Patients enrolling in this research repository must also be enrolled in STUDY00002775 wherein they have consented to use CHAMP App Per STUDY00002775, patients will be at least one month old Parent-Legally authorized representative can read one of the eleven languages that the CHAMP App is available in.

Exclusion Criteria:

• • All patients and parents/Legally authorized representative not meeting the above specified criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding difficulty management	Percent of patients eating all calories by mouth at the end of asynchronous remote monitoring period for feeding management	12 months

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Lori Erickson, PhD, Director, Remote Health Solutions Children's Mercy

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mHealth; Software Platform; asynchronous remote monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Feeding and Eating Disorders of Childhood
• Other Study ID Numbers: STUDY00002753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No