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Impact of Transition Programs on Readiness and Quality of Life in IBD

NCT06946810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-04-27

No results posted yet for this study

Summary

This study is a randomized controlled trial comparing two transition models for adolescents with inflammatory bowel disease (IBD) moving from pediatric to adult care. Patients aged 16-19 years with IBD will be randomized to either a letter-based transition approach (involving a referral supported by a pediatrician's clinical report) or a combined visits-based approach (including joint consultations with both pediatric and adult gastroenterologists).

The primary outcome will be transition readiness assessed using the Transition Readiness Assessment Questionnaire (TRAQ). Secondary outcomes include quality of life (measured by the Pediatric Quality of Life Inventory™), disease activity, and healthcare utilization. Participants will be evaluated at baseline, six months, and one year. The study aims to establish an evidence-based transition model by determining which approach better facilitates a successful transition from pediatric to adult gastroenterology care for young patients with IBD.

Conditions

  • Inflammatory Bowel Disease (IBD)

Interventions

BEHAVIORAL

Combined visits-based transition

In this arm, patients experience a gradual transition involving joint consultations where both pediatric and adult gastroenterologists are present. This includes at least one combined visit at the pediatric clinic and one at the adult clinic, allowing for collaborative care and direct communication between all parties during the transition process.

BEHAVIORAL

Letter-based transition

In this arm, patients are transitioned from pediatric to adult gastroenterology care through a referral system where the pediatrician prepares a comprehensive clinical report that accompanies the patient to their first adult gastroenterology appointment. The transition occurs without joint visits between pediatric and adult specialists.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06946810 on ClinicalTrials.gov