An interventional study of MyIBD in Inflammatory Bowel Diseases, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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:
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.
Quality of care for youth with chronic disease suffers because of gaps in care coordination and communication among patients/families and multiple health care providers. As youth with inflammatory bowel disease (IBD) have preventive and acute care needs beyond those of peers, IBD provides an excellent use case to evaluate interventions to enhance coordination and improve quality. Electronic health records (EHRs) have unfulfilled potential to facilitate coordination and effective action among teams of providers and families. This project leverages web-based and mobile phone application access points to share patient-specific information from an IBD center's EHR. The intervention, MyIBD, has been developed with systematic input from patients, families, and providers. Our objective is to assess the feasibility of delivering tailored guidance on IBD-related health needs to families and care team members using a low-cost, low-risk health communication innovation using existing health information technology. The rationale is that brief, actionable, individually tailored guidance from IBD specialists to families and other providers will support decisions about seeking and providing timely preventive and acute care. Though the intervention builds on prior work and evidence and has been pilot tested, it requires feasibility testing in practice prior to large-scale evaluation. We will assess feasibility of MyIBD through a pilot randomized, controlled trial at one site (n=60). The study has three research aims: (1) assess the feasibility of a rollout effectiveness trial design; (2) assess the feasibility and acceptability of implementing MyIBD in a pediatric IBD clinic; (3) explore the feasibility of MyIBD to improve (a) care quality measures collected from participants and the EHR and (b) patient self-management. In Aim 1 we will assess subject recruitment, randomization, retention, intervention completion, and contamination of control subjects using a study log. For Aim 2 we will use interviews (will take place after completion of the feasibility trial) and surveys to learn about barriers and facilitators of adoption by IBD clinics and acceptability and appropriateness from the perspectives of patients/families and care providers. For Aim 3 we will use surveys and medical record data to explore change over time in family-reported care quality, patient self-management, and completion of guideline-supported quality indicators for pediatric IBD for intervention and control groups. This project is innovative in seeking to change the default ways that care team members share information and address shared responsibilities. MyIBD targets well-described barriers to coordination and incorporates behavioral strategies of individual tailoring, family participation, expert modeling, and facilitation to streamline information delivery and enhance its relevance, accessibility, and actionability. The proposed study is significant because of its potential to improve health through a low-cost intervention to enhance use of existing health information technology. The study's findings could provide a framework for EHR-supported quality improvements through learning health system research across a range of childhood-onset chronic diseases.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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).
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.
Number of overall participants recruited and randomized
Number (0-60) will be an indicator of feasibility of implementing MyIBD in practice.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
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
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.
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
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.
Time frame: Reported at the end of study year 2
Mean self-management score on the Partners in Health scale at baseline
Measured in the baseline participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Time frame: 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 the 6-month participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Time frame: 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 the 12-month participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Time frame: 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 the baseline participant survey using the Patient Assessment of Chronic Illness Care scale, a 20-item survey with 5 Likert-type responses from 1=None of the time to 5=Always. Item scores are averaged to yield an overall scale score between 1 and 5, with 1 indicating the lowest perceived care quality and 5 indicating the highest.
Time frame: 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 the 12-month participant survey using the Patient Assessment of Chronic Illness Care scale, a 20-item survey with 5 Likert-type responses from 1=None of the time to 5=Always. Item scores are averaged to yield an overall scale score between 1 and 5, with 1 indicating the lowest perceived care quality and 5 indicating the highest.
Time frame: Measured in each participant's 12-month survey; reported at end of study year 2
Number of overall participants who completed a primary care health supervision visit in the past year, baseline
Number (0-60) of participants who report having a primary care health supervision visit with a primary care provider in the past year
Time frame: 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
Number (0-60) of participants who report having a primary care health supervision visit with a primary care provider in the past year
Time frame: 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
Number (0-unknown) of participants who report having completed all special vaccines recommended by IBD clinician (such as Hepatitis B booster dose, pneumococcal polysaccharide vaccine)
Time frame: Measured by self-report in baseline survey; reported at end of study year 1
Number of overall participants who completed special vaccine recommendations, 12 months
Number (0-unknown) of participants who report having completed all special vaccines recommended by IBD clinician (such as Hepatitis B booster dose, pneumococcal polysaccharide vaccine)
Time frame: Measured by self-report in 12-month survey; reported at end of study year 2
Number of overall participants who participated in mood disorder screening in the past year, baseline
Number (0-60) of participants who report participating in any mood disorder screening in the past year
Time frame: Measured by self-report in baseline survey; reported at end of study year 1
Number of overall participants who participated in mood disorder screening in the past year, 12 months
Number (0-60) of participants who report participating in any mood disorder screening in the past year
Time frame: Measured by self-report in 12-month survey; reported at end of study year 2
Average number of non-injury-related visits to an emergency department (ED) in the past year, baseline
Total count of non-injury-related ED visits by participants in the past year divided by the total number of participants
Time frame: Measured by self-report in baseline survey; reported at end of study year 1
Average number of non-injury-related visits to an emergency department (ED) in the past year, 12 months
Total count of non-injury-related ED visits by participants in the past year divided by the total number of participants
Time frame: Measured by self-report in 12-month survey; reported at end of study year 2
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap, Icf
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University of North Carolina, Chapel Hill