NCT07054983

Brief Summary

Recent developments in remote monitoring software can provide a proactive means for data transfer for healthcare teams to communicate with families regarding activities like weaning from feeding tubes. Children's Mercy began utilizing a mHealth technology - CHAMP App® - for tube weaning in the Fall of 2023. Research gaps remain in this population, including comparing the experiences of families who could wean with methods available prior to the innovative use of a medical team collaborating with mHealth technology. This will be a single site study with one-time naturalistic, semi-structured parent interviews of children who have attempted tube weaning in their homes with two different models of care (standard ambulatory tube weaning and with the CHAMP App pilot).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jul 2025Oct 2026

First Submitted

Initial submission to the registry

June 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

June 4, 2025

Last Update Submit

May 14, 2026

Conditions

Keywords

PediatricTube Weaning

Outcome Measures

Primary Outcomes (1)

  • Parental Perspective

    Explore the parental perspectives of the process of weaning from feeding tubes to all calories by mouth while in the home setting to identify preference for weaning via remote health monitoring.

    During the Tube weaning attempt, an average of 8 weeks

Secondary Outcomes (4)

  • Communication

    During the Tube weaning attempt, an average of 8 weeks

  • Stress

    During the Tube weaning attempt, an average of 8 weeks

  • Social Determinates of Health

    During the Tube weaning attempt, an average of 8 weeks

  • Access

    During the Tube weaning attempt, an average of 8 weeks

Study Arms (1)

Parents of children who attempted tube weaning

OTHER

Qualitative interviews of parents of pediatric patients who have previously attempted tube weaning via the CHAMP App

Other: Qualitative Research Interview

Interventions

Qualitative research interview of parents of pediatric patients seen in an interdisciplinary feeding clinic who underwent a tube weaning program

Parents of children who attempted tube weaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults that are at least 18 years of age that are parent(s) of children with pediatric feeding disorder who have been seen in the Children's Mercy Interdisciplinary Feeding Clinic.
  • Parent/Legal Guardian of a child \< 6 years of age when they attempted tube weaning
  • Pediatric patients that have attempted a tube wean in the last 3 years (2022-2025) with the Interdisciplinary Feeding Clinic through either standard of care or through utilization of the CHAMP App

You may not qualify if:

  • Non-English-speaking parent(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Interviews
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 4, 2025

First Posted

July 8, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations