Feasibility Test of Action Planning in Pediatric IBD

NCT06186752 | Recruiting

• 2 other identifiers: 23-2704R03TR004311-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Number of overall participants recruited and randomized

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

  Measured and reported at the end of study year 1

• Number of intervention group participants who receive a MyIBD document

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

  Measured and reported at the end of study year 1

• Number of overall participants retained through baseline survey

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

  Measured and reported at the end of study year 1

• Number of overall participants retained through 6-month survey

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

  Measured and reported at the mid-point of study year 2

• Number of overall participants retained through 12-month survey

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

  Measured and reported at end of study year 2

• Number of control group participants who receive a MyIBD document

  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.

  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

  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.

  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

  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.

  Reported at the end of study year 2

Secondary Outcomes (5)

• Mean self-management score on the Partners in Health scale at baseline

  Measured in each participant's baseline survey; reported at end of study year 1

• Mean self-management score on the Partners in Health scale at 6 months

  Measured in each participant's 6-month survey; reported at end of study year 2

• Mean self-management score on the Partners in Health scale at 12 months

  Measured in each participant's 12-month survey; reported at end of study year 2

• Mean perceived Quality of Care score at baseline using the Patient Assessment of Chronic Illness Care survey

  Measured in each participant's baseline survey; reported at end of study year 1

• Mean perceived Quality of Care score at 12 months using the Patient Assessment of Chronic Illness Care survey

  Measured in each participant's 12-month survey; reported at end of study year 2

Other Outcomes (8)

• Number of overall participants who completed a primary care health supervision visit in the past year, baseline

  Measured by self-report in baseline survey; reported at end of study year 1

• Number of overall participants who completed a primary care health supervision visit in the past year, 12 months

  Measured by self-report in 12-month survey; reported at end of study year 2

• Number of overall participants who completed special vaccine recommendations, baseline

  Measured by self-report in baseline survey; reported at end of study year 1

Study Arms (2)

MyIBD

EXPERIMENTAL

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.

Behavioral: MyIBD

Usual Care

NO INTERVENTION

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 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.

MyIBD

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• speaker of a language other than English or Spanish

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of North Carolina-Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Neal deJong, MD

  UNC-Chapel Hill School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal deJong, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant in charge of sending out electronic surveys for data collection will be masked to participants' group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 overall to intervention and control using permuted blocks (four) designed according to each alphabetic cluster's assigned nurse coordinator.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: February 5, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become 9 to 36 months following publication and will remain available as long as the principal investigator remains actively working.
• Access Criteria: See Plan Description section above for IRB or similar authorization prior to access. Once those criteria have been met, an interested investigator may contact the study PI by email (dejong@med.unc.edu); the PI would arrange for deidentified data sharing in accordance with university policy.

Locations

US (1)