Feasibility Test of Action Planning in Pediatric IBD
Not applicable · Testing MyIBD · 1 site · University of North Carolina, Chapel Hill
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing MyIBD (a behavioral program) to improve how care is delivered. Condition(s) listed: Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 13 to 19
- Any sex
Some of the main requirements, copied from the record:
- age 13-19 years old at time of recruitment; AND
- diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND
- receiving ongoing care at UNC (at least one visit in the past year)
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2024-02-05.
- Main results expected around 2026-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Number of overall participants recruited and randomized (Measured and reported at the end of study year 1)
In the researchers’ words
The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question\[s\] it aims to answer are: * Is the MyIBD communication tool feasible to use in everyday clinical practice? * Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive?
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Collaborators | National Center for Advancing Translational Sciences (NCATS) |
| Enrollment | 60 (estimated) |
| Start date | 2024-02-05 |
| Primary completion (est.) | 2026-03 |
| First posted | 2024-01-02 |
| Last updated | 2025-05-08 |
| Official title | Feasibility of a Care Team-Focused Action Plan to Improve Quality of Care for Children and Adolescents With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06186752 |
Interventions
- MyIBD (Behavioral)
MyIBD has two components: (1) an electronic, templated document that presents brief, actionable, tailored guidance from IBD specialists to families and other providers who care for a pediatric patient with IBD; and (2) regular, short prompts sent through the electronic patient portal to remind patients to refer to and use their MyIBD document to guide decisions about care in between appointments.
Full eligibility criteria (from the record)
Inclusion Criteria: * age 13-19 years old at time of recruitment; AND * diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND * receiving ongoing care at UNC (at least one visit in the past year) Exclusion Criteria: * speaker of a language other than English or Spanish
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina-Chapel Hill School of Medicine | Chapel Hill, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.