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Feasibility Test of MyIBD for Pediatric Inflammatory Bowel Diseases

This study is testing a new communication tool called MyIBD for young people aged 13 to 19 with inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis. MyIBD is designed to give families and doctors clear, tailored advice from IBD specialists. The main goal is to see if MyIBD can be easily used in everyday clinic visits and if it might help you manage your condition better and improve the care you receive. If you join, you'll complete surveys about your care when you start, and then again at 6 months and 12 months. This will help researchers understand if MyIBD is a helpful tool. The study aims to enroll 60 participants who receive ongoing care at UNC.

Study design
This is an interventional study, meaning participants will receive a specific intervention (MyIBD). It plans to enroll 60 participants and will randomize them into groups.
What's involved
Participants will complete surveys about their care at enrollment, 6 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after enrollment, with surveys at 6 and 12 months.

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NCT06186752

Feasibility Test of Action Planning in Pediatric IBD

Recruiting
NAAges 13–19InterventionalHealth services
University of North Carolina, Chapel Hill
~60 participants
Updated 2025-05-08 on ClinicalTrials.gov
What's tested:MyIBD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of overall participants recruited and randomized
Measured over Measured and reported at the end of study year 1
+7 more outcomes measured

Conditions

Inflammatory Bowel Diseases

Explore related trials

Colitis of Indeterminate TypeCrohn DiseaseInflammatory Bowel DiseaseUlcerative Colitis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Neal deJong, MD · PRINCIPAL_INVESTIGATOR · UNC-Chapel Hill School of Medicine

Who to contact

Neal deJong, MD
[email protected]
919-966-2504
Email the study team

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Eligibility criteria

Inclusion

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

speaker of a language other than English or Spanish

What this trial measures

  • Number of overall participants recruited and randomizedMeasured and reported at the end of study year 1

    Number (0-60) will be an indicator of feasibility of implementing MyIBD in practice.

  • Number of intervention group participants who receive a MyIBD documentMeasured and reported at the end of study year 1

    Number (0-30) of intervention-group participants who receive a MyIBD document will estimate the degree of completion of the intervention in practice.

  • Number of overall participants retained through baseline surveyMeasured and reported at the end of study year 1

    Number (0-60) of participants who complete the baseline survey

  • Number of overall participants retained through 6-month surveyMeasured and reported at the mid-point of study year 2

    Number (0-60) of participants who complete the 6-month survey

  • Number of overall participants retained through 12-month surveyMeasured and reported at end of study year 2

    Number (0-60) of participants who complete the 12-month survey

  • Number of control group participants who receive a MyIBD documentMeasured and reported at the end of study year 1

    Number (0-30) of control-group participants who (inappropriately) receive a MyIBD document is an indicator of contamination, or spreading the intervention in practice to the control group.

  • Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention MeasureReported at the end of study year 2

    Measured in the 12-month participant survey using the Acceptability of Intervention Measure (AIM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of acceptability and 5 indicating the highest level.

  • Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness MeasureReported at the end of study year 2

    Measured in the 12-month participant survey using the Intervention Appropriateness Measure (IAM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of appropriateness and 5 indicating the highest level.