CHAMP App Feeding Difficulties Repository

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06129877
Collaborator
The Gerber Foundation (Other)
1,000
1
85.7
11.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
CHAMP App Feeding Difficulties Repository
Actual Study Start Date :
Nov 9, 2023
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2030

Outcome Measures

Primary Outcome Measures

  1. Feeding difficulty management [12 months]

    Percent of patients eating all calories by mouth at the end of asynchronous remote monitoring period for feeding management

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Mercy Kansas City Kansas City Missouri United States 64108

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City
  • The Gerber Foundation

Investigators

  • Principal Investigator: Lori Erickson, PhD, Director, Remote Health Solutions Children's Mercy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lori Erickson, Principal Investigator, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT06129877
Other Study ID Numbers:
  • STUDY00002753
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Lori Erickson, Principal Investigator, Children's Mercy Hospital Kansas City
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023