CHAMP For the Feeder: Tube Feeding Study (NCT06052891) | Clinical Trial Compass
By InvitationNot Applicable
CHAMP For the Feeder: Tube Feeding Study
United States245 participantsStarted 2023-11-09
Plain-language summary
Single site evidence-based implementation of a mHealth application for remote patient monitoring for pediatric patients ready to wean from tube feedings (TFs). The primary objective of this study is to evaluate the CHAMP® ("CHAMP App") software platforms' expansion into TF weaning through Children's Mercy (CM) Kansas City's interdisciplinary feeding team (IDC). The investigators will use the current standard of care rates of tube weaning success, time to weaning, and healthcare team communication to evaluate the change after the implementation of the evidence-based CHAMP App. For equipoise of access, the study team will provide access in this pre-post design for parent/legally authorized representative (LAR)- child family access and use the CHAMP App software platform as soon as possible.
Who can participate
Age range
1 Month – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Eligibility Criteria: Parent/LAR-Child dyad was referred for feeding difficulty and tube feeding care at Children's Mercy.
* Inclusion Criteria
* The child is between the ages of 1 month and five years 11 months.
* Child is approved for a trial of tube weaning by the managing providers of their feeding difficulty.
* Exclusion Criteria
* Children who do not meet the criteria to begin tube weaning.
* Children who are older than 6 years of age at time of enrollment.
* Parent/LAR of parent/LAR-child dyad who do not speak one of the languages offered via the CHAMP application (English, Spanish, German, Chinese, Vietnamese, Arabic, Korean, French, Filipino, Burmese or Somali).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence Initiation
Timeframe: Time in days, one event- the first day of data transfer of CHAMP App data after enrollment
2
Adherence Implementation
Timeframe: From enrollment to study endpoint, an average of 6 weeks
3
Adherence Discontinuation
Timeframe: From enrollment to study endpoint, an average of 6 weeks
4
Success rate to tube weaning
Timeframe: From enrollment to study endpoint, an average of 6 weeks
5
Time to weaning
Timeframe: From enrollment to study endpoint, an average of 4 weeks