MyIBD Tool for Pediatric IBD

Overseen by Neal deJong, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English/Spanish speakers

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a communication tool, so it's likely you can continue your usual treatment.

What data supports the effectiveness of the MyIBD Communication Tool treatment for pediatric IBD?

The research highlights the importance of increasing disease-related knowledge to improve treatment adherence in children with IBD, suggesting that tools like MyIBD Communication Tool, which enhance understanding, could be beneficial in managing the condition. ^{1 2 3 4 5}

How does the MyIBD Tool treatment for pediatric IBD differ from other treatments?

The MyIBD Tool is unique because it focuses on improving disease and treatment knowledge among children with IBD, which can enhance adherence to complex treatment regimens. Unlike traditional treatments that focus solely on medication, this tool aims to empower children through education, potentially leading to better disease management. ^{1 2 3 4 6}

Research Team

Neal deJong, MD

Principal Investigator

UNC-Chapel Hill School of Medicine

Eligibility Criteria

This trial is for young people aged 13 to 19 who have inflammatory bowel disease. To join, they must be willing to use the MyIBD communication tool and complete several surveys about their care over a year. Specific details on what conditions would exclude someone from participating are not provided.

Inclusion Criteria

I am between 13 and 19 years old.

Receiving ongoing care at UNC (at least one visit in the past year)

I was diagnosed with Crohn's, ulcerative colitis, or indeterminate colitis over 3 months ago.

Exclusion Criteria

I speak a language other than English or Spanish.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the MyIBD communication tool and complete surveys at enrollment, 6 months, and 12 months

12 months

3 visits (in-person or virtual) at enrollment, 6 months, and 12 months

Follow-up

Participants are monitored for changes in self-management skills and quality of care

4 weeks

Treatment Details

Interventions

• MyIBD (Behavioral Intervention)

Trial Overview The study is testing a new tool called MyIBD designed to help teenagers with IBD manage their condition better. It will compare the experiences of those using MyIBD against those receiving standard care by assessing self-management skills and quality of care through surveys at different intervals.

Participant Groups

Group I: MyIBD Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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).

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Findings from Research

The IBD-KID tool, designed to assess knowledge in children with inflammatory bowel disease, showed that 52% of its items had an acceptable difficulty level, and 74% effectively distinguished between children with high and low knowledge scores, indicating its potential utility in improving treatment adherence.

However, the analysis revealed areas for improvement, such as complex multiple-choice items and varying comprehension levels among children, suggesting that revisions are needed to enhance clarity and effectiveness without compromising the tool's reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response pattern analysis of IBD-KID: A knowledge assessment tool for children with inflammatory bowel disease. Vernon-Roberts, A., Otley, A., Frampton, C., et al.[2021]

A survey of over 100 ImproveCareNow centers revealed significant variability in the availability and types of psychosocial support for youth with pediatric inflammatory bowel disease (IBD), highlighting gaps in care.

While multidisciplinary support is recognized as beneficial for managing the psychosocial impacts of IBD, it is not consistently accessible, indicating a need for further research and expansion of these services across care centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of Psychosocial Services Within the ImproveCareNow Learning Health System: Opportunities for Optimization. Winnick, JB., Jacobs, N., David, JG., et al.[2023]

There is a critical need for better trial designs in pediatric inflammatory bowel disease (PIBD) to ensure that medications are not prescribed off-label without sufficient pediatric data, as highlighted by the Pediatric Inflammatory Bowel Disease Network (PIBDnet).

The position paper outlines 18 consensus statements to guide the design of clinical trials in PIBD, focusing on aspects like eligibility criteria, dosing, and endpoints, aiming to facilitate ethical and high-quality drug approval for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing clinical trials in paediatric inflammatory bowel diseases: a PIBDnet commentary. Turner, D., Griffiths, AM., Wilson, D., et al.[2023]

The pilot study involving 35 adolescents and young adults with ulcerative colitis showed that the web-based tool 'iBDecide' was user-friendly and helped participants feel more prepared for decision-making regarding their treatment.

Although the tool was well-received, the actual engagement in decision-making during clinic visits was low, indicating a need for further development and testing of the intervention in a larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis. Matula, KA., Minar, P., Daraiseh, NM., et al.[2022]

The IBD-KID is a validated tool that effectively measures disease-specific knowledge in Australian children with inflammatory bowel disease (IBD), showing that children with longer disease duration have better knowledge than those recently diagnosed.

Parents of children with IBD scored higher in disease knowledge assessments than their children, indicating a potential gap in understanding that could be addressed through targeted education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generalisability of the inflammatory bowel disease knowledge inventory device to assess disease-related knowledge in Australian children. Day, AS., Lemberg, DA., Nichol, A., et al.[2019]

The IBD-KID2 tool effectively distinguishes between children with inflammatory bowel disease (IBD) and those without, as well as medical and administrative staff, demonstrating its validity in assessing knowledge levels about IBD.

The tool shows strong reliability with a test-retest correlation coefficient of 0.82 and an internal reliability score of 0.85, indicating it is a consistent and dependable method for evaluating IBD knowledge in children aged 8 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a Revised Knowledge Assessment Tool for Children with Inflammatory Bowel Disease (IBD-KID2). Vernon-Roberts, A., Otley, A., Frampton, C., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Response pattern analysis of IBD-KID: A knowledge assessment tool for children with inflammatory bowel disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Variability of Psychosocial Services Within the ImproveCareNow Learning Health System: Opportunities for Optimization. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Designing clinical trials in paediatric inflammatory bowel diseases: a PIBDnet commentary. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Generalisability of the inflammatory bowel disease knowledge inventory device to assess disease-related knowledge in Australian children. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of a Revised Knowledge Assessment Tool for Children with Inflammatory Bowel Disease (IBD-KID2). [2022]