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

NAActive, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

February 25, 2022

Primary Completion Date

July 1, 2025

Study Completion Date

December 31, 2025

Conditions
Inflammatory Bowel DiseasesCrohn DiseaseUlcerative ColitisAdolescent DevelopmentTransitionMental Health Wellness 1
Interventions
BEHAVIORAL

Multimodal intervention consisting of four core components

"Core Component 1: Individualized Assessment: Each participant will undergo individualized assessment of their biopsychosocial risk profile (PIBD INTERMED), self-efficacy (IBD-SES-A), function (IBD-DI), transition readiness (TRAQ) and IBD knowledge (IBD-KID2), and depression, anxiety and activation.~Core Component 2: Transition Navigator: Participants will be assigned a transition navigators, who will have knowledge of IBD, an understanding of the care pathway involved in transitioning IBD patients, and the skills and ability to provide psychosocial support.~Core Component 3: Participant Skills-building: Skills-building materials delivered virtually. Navigators will also be trained as motivational coaches and will lead separate personalized virtual sessions targeting individual skills that have been identified as deficient during the assessment phase.~Core Component 4: eLearning Curriculum: Organized online eLearning modules with reinforcement of knowledge by the navigators."

BEHAVIORAL

Standard of care

"The control group will be provided a standardized version of routine care for transition. In addition to recruiting centers' standard of care, all participating centers will implement the following transition interventions:~1. A written letter explaining the goals of transition to the patient and family.~2. Completion of age-appropriate checklists to ensure adolescents are meeting milestones of transition (developed by the TRACC Network).51~3. Annual online live educational webinars on transition and adolescent issues (hosted by the CIDsCaNN Education Committee).~4. Completion of the Pediatric INTERMED,52 with appropriate biopsychosocial intervention.~5. Completion of a transfer-of-care summary letter sent to the receiving adult gastroenterologist using a standardized letter template.53~The Control Group may also receive any interventions currently in place in their participating care center, but will not receive the formal 4-component intervention described below."

Trial Locations (3)

V6H 3N1

BC Children's Hospital, Vancouver

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
collaborator

Crohn's and Colitis Canada

OTHER

collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

collaborator

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

UNKNOWN

collaborator

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

UNKNOWN

lead

The Hospital for Sick Children

OTHER