Feasibility Test of Action Planning in Pediatric IBD

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06186752
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
13 Years - 19 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 5, 2024
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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).

Primary Outcome Measure

Number of overall participants recruited and randomized [ Time Frame: Measured and reported at the end of study year 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina-Chapel Hill School of MedicineChapel HillNorth Carolina27599
Neal deJong, MD
[email protected]
919-966-2504

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By research site
University of North Carolina-Chapel Hill School of Medicine· Chapel Hill, NC

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