Recruiting

Observational Study

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06186752

Conditions

Inflammatory Bowel Diseases

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Not accepted

Interventions

MyIBD

Study Details

Brief summary:

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?

Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care.

Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.

Conditions

Inflammatory Bowel Diseases

Study ID

NCT06186752

Start date

Feb 5, 2024

Status verified date

Apr, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: MyIBD

Each participant randomized to the intervention arm (MyIBD) will receive an individually tailored MyIBD document within a week of a scheduled outpatient clinic visit. The MyIBD document will be prepared by the patient's usual, assigned nurse coordinator together with the study's clinical champion (a nurse practitioner in the IBD program). Participants will receive a copy of the MyIBD document with language suggesting that they use it to guide decisions about care in between appointments. Each participant's primary care provider will also receive a copy of the MyIBD document. The nurse coordinator will send reminder messages to intervention-group participants (using the electronic patient portal) to access and use their MyIBD document at 1-2 months, 3-4 months, 7-8 months, and 11-12 months after initial plan creation.

no intervention: Usual Care

Each participant randomized to the control group will receive usual care in the pediatric IBD program. They will be eligible to receive a MyIBD document after completing the study (12 months after enrollment).

Interventions

MyIBD

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.

Primary outcome measure

  • Number of overall participants recruited and randomized [ Time Frame: Measured and reported at the end of study year 1 ]
  • Number of intervention group participants who receive a MyIBD document [ Time Frame: Measured and reported at the end of study year 1 ]
  • Number of overall participants retained through baseline survey [ Time Frame: Measured and reported at the end of study year 1 ]
  • Number of overall participants retained through 6-month survey [ Time Frame: Measured and reported at the mid-point of study year 2 ]
  • Number of overall participants retained through 12-month survey [ Time Frame: Measured and reported at end of study year 2 ]
  • Number of control group participants who receive a MyIBD document [ Time Frame: Measured and reported at the end of study year 1 ]
  • Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention Measure [ Time Frame: Reported at the end of study year 2 ]
  • Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness Measure [ Time Frame: Reported at the end of study year 2 ]

Central Contacts and Locations

Central contacts

Neal deJong, MD

919-966-2504dejong@med.unc.edu

Locations

University of North Carolina-Chapel Hill School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Neal deJong, MD

919-966-2504dejong@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-05-08.