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Multimodal Intervention for Crohn's Disease Transition Care

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

Fecal calprotectin

Hospitalization after 18th birthday (yes/no)

+12 more

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

2019

Completed Phase 4

~16090

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

686 Previous Clinical Trials

6,944,678 Total Patients Enrolled

Crohn's and Colitis CanadaOTHER

7 Previous Clinical Trials

1,217 Total Patients Enrolled

The Leona M. and Harry B. Helmsley Charitable TrustOTHER

57 Previous Clinical Trials

93,803 Total Patients Enrolled

Media Library

Multimodal intervention consisting of four core components Clinical Trial Eligibility Overview. Trial Name: NCT05221281 — N/A

Inflammatory Bowel Disease Clinical Trial 2023: Multimodal intervention consisting of four core components Highlights & Side Effects. Trial Name: NCT05221281 — N/A

Multimodal intervention consisting of four core components 2023 Treatment Timeline for Medical Study. Trial Name: NCT05221281 — N/A

Inflammatory Bowel Disease Research Study Groups: Intervention: Multimodal intervention consisting of four core components., Control: Standard of care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met in order to take part in this clinical trial?

"This research initiative seeks 115 adolescents aged 16 to 17.5 years old suffering from inflammatory bowel diseases who are able to converse, read and write English at a functional (Grade 8) level, own a smartphone or laptop for the virtual intervention, and plan on residing in Canada once transferred into adult care."

Answered by AI

Is geriatric participation welcomed in this research endeavor?

"This clinical trial is targeting patients aged 16 to 17, but there are also 136 research studies for minors and 386 studies that seek participants over 65 years old."

Answered by AI

Are any new volunteers needed for this research project?

"Clinicaltrials.gov data confirms that this research project is still actively enrolling participants. According to the records, it was first posted on February 25th 2022 and has undergone no changes since then."

Answered by AI

How many individuals are permitted to join this experiment?

"Confirmed. The clinical trial is actively looking for participants, as depicted on the page hosted by clinicaltrials.gov. This investigation was initially advertised on February 25th 2022 and has since been updated with a requirement of 115 recruitments across 4 sites."

Answered by AI

Are there any established locations in North America where this scientific experiment is being conducted?

"Four medical centres are currently running this study, including BC Children's Hospital in Vancouver, McMaster Children's Hospital in Hamilton and The Hospital for Sick Childern in Toronto. Additionally, there exists other sites that offer the same services."

Answered by AI

Recent research and studies

BMC GastroenterologyJournal

Multimodal Intervention to Improve the Transition of Patients with Inflammatory Bowel Disease from Pediatric to Adult Care: Protocol for a Randomized Controlled Trial

Bollegala, Natasha, Melanie Barwick, Nancy Fu, Anne M. Griffiths, Laurie Keefer, Sara Ahola Kohut, Karen I. Kroeker, et al.. 2022. “Multimodal Intervention to Improve the Transition of Patients with Inflammatory Bowel Disease from Pediatric to Adult Care: Protocol for a Randomized Controlled Trial”. BMC Gastroenterology. Springer Science and Business Media LLC. doi:10.1186/s12876-022-02307-9.

clinicaltrials.govStudy

Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

Eric Benchimol 2022. "Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05221281.

All > Inflammatory Bowel Disease > Crohns Disease