Multimodal Intervention for Crohn's Disease Transition Care

Not currently recruiting at 3 trial locations
EI
Jd
Overseen ByJacqueline de Guzman
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The Hospital for Sick Children
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to help young people with Crohn's disease and other inflammatory bowel diseases (IBD) transition from pediatric to adult healthcare. The program offers a special plan that includes a personal assessment, a transition guide, skill-building, and an online education course. The trial aims to improve how young patients manage their condition and prepare them for adult healthcare. Participants aged 16 to 17.5 years who have been diagnosed with IBD, speak English, plan to stay in Canada, and can use a smartphone or computer for the program are eligible. As an unphased trial, this study provides a unique opportunity to contribute to research that could ease the transition to adult healthcare for future patients.

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 prior data suggests that this protocol is safe for transitioning adolescents and young adults with IBD?

Research has shown that this program is designed to help young people with Crohn's disease transition from child to adult healthcare. Specific data on handling this program is limited, as it emphasizes skill-building and education rather than medication.

This type of program typically doesn't cause physical side effects, as it centers on learning and support. The methods align with other educational and support programs, which are generally safe and well-tolerated. Participants will use online resources, minimizing risk.

Joining this trial means participating in a program that aims to ease and enhance the transition to adult care. Overall, the risks are very low, with a focus on helping participants gain knowledge and confidence in managing their condition.12345

Why are researchers excited about this trial?

Researchers are excited about the multimodal intervention for Crohn's Disease transition care because it offers a comprehensive approach that goes beyond standard treatments like medication and routine care. Unlike typical treatments, which often focus solely on managing symptoms with drugs, this intervention emphasizes personalized care with four key components: individualized assessments, transition facilitation with a navigator, skills-building for participants, and a structured educational eLearning curriculum. This holistic strategy aims to empower patients by equipping them with the knowledge and skills necessary to manage their condition more effectively as they transition from pediatric to adult care, potentially leading to better long-term outcomes.

What evidence suggests that this multimodal intervention is effective for improving transition care in Crohn's Disease?

This trial will compare a multimodal intervention with standard care for young people transitioning from child to adult care for Crohn's Disease. The multimodal intervention includes personalized check-ups, assistance from a transition guide, skill-building sessions, and an online learning program. These components aim to enhance patient skills, self-care, and confidence. Early results from similar programs suggest that such interventions can better prepare patients for the transition. Although the long-term effects of this specific program are still under study, it is designed to address the challenges young patients encounter when moving to adult healthcare.12346

Who Is on the Research Team?

EI

Eric I Benchimol, MD, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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 have been diagnosed with inflammatory bowel disease.
I am between 16 and 17.5 years old.
Ability to use a smartphone or personal computer for the virtual intervention
See 2 more

Exclusion Criteria

Intention to leave Canada after graduation from high school
I am not fluent in English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Intervention: Multimodal intervention consisting of four core components.Experimental Treatment1 Intervention
Group II: Control: Standard of careExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Multimodal intervention to improve the transition of patients ...Outcomes data on adolescents with IBD are limited, and there are even fewer data on how the transition of care affects long-term treatment and outcomes.
Multimodal intervention to improve the transition of patients ...Structured online eLearning program to build patient knowledge about the transition from pediatric to adult care and living with IBD as a ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35585484/
Multimodal intervention to improve the transition of patients ...This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention.
Study Details | NCT05221281 | Implementing a Multimodal ...This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving ...
Implementing a Multimodal RCT Intervention to Improve the ...This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving ...
Multimodal intervention to improve the transition of patients ...This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention ...
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