Multimodal Intervention for Crohn's Disease Transition Care

Recruiting at 3 trial locations

Overseen By Jacqueline de Guzman

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Non-English speakers, Leaving Canada

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

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.

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 improving transition care for young people with IBD, so it's best to ask the trial coordinators for specific guidance.

What data supports the effectiveness of this treatment for Crohn's Disease?

Research shows that structured transition care for adolescents with inflammatory bowel disease (IBD), which includes Crohn's Disease, can lead to better long-term health outcomes and higher remission rates. While the specific multimodal intervention in the trial isn't directly studied, the positive outcomes from structured transition care suggest that comprehensive approaches can be beneficial. ^{1 2 3 4 5}

How is the multimodal intervention for Crohn's Disease transition care different from other treatments?

This treatment is unique because it focuses on improving the transition from pediatric to adult care for young adults with Crohn's Disease, using a comprehensive approach that addresses medical, psychological, and social aspects, unlike standard treatments that primarily focus on medical management. ^{2 5 6 7 8}

Research Team

Eric I Benchimol, MD, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for English-speaking adolescents aged 16 to 17.5 years with Inflammatory Bowel Disease (IBD), planning to stay in Canada after transitioning to adult care, and who can use a smartphone or computer for virtual interventions.

Inclusion Criteria

I am between 16 and 17.5 years old.

I have been diagnosed with inflammatory bowel disease.

Ability to use a smartphone or personal computer for the virtual intervention

Exclusion Criteria

Intention to leave Canada after graduation from high school

I am not fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a multimodal intervention consisting of individualized assessment, transition navigator, virtual skills-building, and structured education program

24 months

Virtual sessions as per intervention components

Follow-up

Participants are monitored for transition readiness, self-efficacy, and health service utilization

24 months

Long-term Follow-up

Participants are assessed for health service utilization and disease activity post-transition to adult care

3 years

Treatment Details

Interventions

• Multimodal intervention consisting of four core components
• Standard of care

Trial Overview The study tests a multimodal intervention against standard care in improving the transition of young IBD patients from pediatric to adult healthcare. The program includes individual assessments, a transition navigator, virtual skills-building, and an education program.

Participant Groups

Group I: Intervention: Multimodal intervention consisting of four core components. Experimental Treatment 1 Intervention

Core Component 1: Individualized Assessment Core Component 2: Transition Facilitation with a Navigator Core Component 3: Participant Skills-building Core Component 4: Structured Educational eLearning Curriculum

Group II: Control: Standard of care Experimental Treatment 1 Intervention

Routine Care

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Crohn's and Colitis Canada

Collaborator

Trials

8

Recruited

1,300+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

The Canadian Children Inflammatory Bowel Disease Network: A Partnership with the CH.I.L.D. Foundation

Collaborator

Trials

1

Recruited

90+

The CH.I.L.D. Foundation - Children with Intestinal & Liver Disorders

Collaborator

Trials

1

Recruited

90+

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term implications of structured transition of adolescents with inflammatory bowel disease into adult health care: a retrospective study. [2020]

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

Improving IBD Transition, Self-management, and Disease Outcomes With an In-clinic Transition Coordinator. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

A transition clinic model for inflammatory bowel disease between two tertiary care centers: outcomes and predictive factors. [2021]

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

Planned Transition of Adolescent Patients with Inflammatory Bowel Disease Results in Higher Remission Rates. [2019]

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

Assessing the Transition Intervention Needs of Young Adults With Inflammatory Bowel Diseases. [2019]

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

Using a Mixed-method Approach to Develop a Transition Program for Young Adults With Inflammatory Bowel Disease. [2021]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Pediatric to adult inflammatory bowel disease transition: the Asian experience. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial. [2022]