MyIBD Tool for Pediatric IBD

Overseen By Neal deJong, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-English/Spanish speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new communication tool called MyIBD for teenagers with inflammatory bowel disease (IBD). The goal is to determine if MyIBD can help young patients manage their condition better and improve the quality of care they receive. Participants will complete surveys at various times to help researchers assess the usefulness and effectiveness of MyIBD. The study will compare the outcomes of those using MyIBD with those receiving regular care. Teens aged 13 to 19 who have had Crohn's disease or colitis for at least three months and are receiving care at UNC may be eligible to join. As an unphased trial, this study offers a unique opportunity for teens to contribute to innovative care solutions and potentially enhance their own health management.

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 prior data suggests that the MyIBD communication tool is safe for use in pediatric patients with inflammatory bowel disease?

A previous study tested the MyIBD tool to assess its effectiveness in helping kids and teens with inflammatory bowel disease (IBD) communicate. Research shows that tools like MyIBD are safe, primarily aiding patients in managing their care and communicating with healthcare providers.

The study does not involve a new drug or invasive treatment, so it reports no physical side effects or problems often associated with direct medical treatments. Instead, this tool aims to improve the care experience. As it is neither a drug nor a procedure, it is expected to be user-friendly and free of issues. No evidence suggests any safety concerns related to MyIBD.

Overall, MyIBD is designed to enhance patients' health management with their healthcare team's support, posing no risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MyIBD for pediatric inflammatory bowel disease (IBD) because it offers a personalized approach to managing the condition. Unlike standard treatments that focus on medication and routine clinical visits, MyIBD provides a tailored document crafted by healthcare professionals that guides patients in making informed decisions about their care between appointments. This innovative method also keeps primary care providers in the loop and includes regular reminders to encourage consistent use, potentially improving patient engagement and outcomes.

What evidence suggests that the MyIBD communication tool is effective for improving self-management skills and quality of care in pediatric IBD?

This trial will compare the MyIBD tool with usual care for young people with inflammatory bowel disease (IBD). Research has shown that the MyIBD tool might help young people manage their health and improve their healthcare. Although clinical data remains limited, the tool is designed to assist patients in making better care decisions between doctor visits. Early signs suggest that tools like this can help patients manage their condition more effectively. MyIBD aims to offer personalized advice, potentially leading to better management of IBD in children and teens. Current studies are examining the tool's practicality and usefulness in everyday life. ^{1 5 6 7 8}

Who Is on the Research Team?

Neal deJong, MD

Principal Investigator

UNC-Chapel Hill School of Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MyIBD

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.

How Is the Trial Designed?

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+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-inflammatory-bowel-diseases-2024-f40d6

MyIBD Tool for Pediatric IBD 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 ...

2. trialstoday.org trialstoday.org/trial/NCT06186752

Feasibility Test of Action Planning in Pediatric IBD 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674067/

Patient-Reported Outcomes Measurement Information System ... The PROMIS is a non-disease-specific instrument for both adults and pediatric patients assessing domains of physical, psychological, and social health, as well ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1876285921006483

Interpreting Patient-Reported Outcome Scores: Pediatric ... This study established IBD-specific percentiles for 6 pediatric PROMIS measures and demonstrated the application of percentiles and other methods for ...

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.615216/full

An Overview of Tools to Score Severity in Pediatric ... This review aims to highlight key tools available for the assessment of disease activity or severity in individuals (especially children) with IBD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11883196/

Inflammatory Bowel Disease in Children: Current ... This article reviews current diagnostic and emerging treatment strategies to highlight the evolution from traditional therapies such as aminosalicylates, ...

7. mdpi.com mdpi.com/2227-9067/11/12/1492

Patient-Reported Outcomes Measurement Information ... The PROMIS is a non-disease-specific instrument for both adults and pediatric patients assessing domains of physical, psychological, and social health, as well ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03571373

PIBD-SETQuality: the Inception Cohort and Safety Registry The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset ...