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Multimodal Intervention for Crohn's Disease Transition Care

N/A

Waitlist Available

Led By Eric I Benchimol, MD, PhD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with IBD diagnosed using standard criteria

Aged 16-17.5 years

Must not have

Do not speak English fluently

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness 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. The intervention includes individualized assessment, a transition navigator, and virtual patient skills-building and education programs.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on educational and support interventions rather than medication, traditional side effects are not applicable. However, participants may experience varying levels of engagement or stress related to using digital platforms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with inflammatory bowel disease.

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I am between 16 and 17.5 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not fluent in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Emergency department visit after 18th birthday (yes/no)

Fecal calprotectin

Hospitalization after 18th birthday (yes/no)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention: Multimodal intervention consisting of four core components.Experimental Treatment1 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 careExperimental Treatment1 Intervention

Routine Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of care

2020

Completed Phase 4

~17710

0 / 3Eligibility criteria met