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

NCT06946810 | Completed

• 1 other identifier: 5385/AO/22
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Transition; Pediatric; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Transition readiness as measured by the Transition Readiness Assessment Questionnaire (TRAQ)

  The TRAQ is a validated 20-item questionnaire that assesses youths' ability to manage their health independently. It evaluates five domains: Appointment Keeping, Tracking Health Issues, Managing Medications, Talking with Providers, and Managing Daily Activities. Scores range from 1-5 for each item, with higher scores indicating greater transition readiness.

  Baseline and at end of transition period (approximately 12 months)

Secondary Outcomes (9)

• Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)

  Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)

• Healthcare utilization

  Throughout study period (Month 0 to Month 12)

• Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)

  Baseline (T0), intermediate visit (T2), and end of transition period (T3, approximately 12 months)

• Disease activity in Crohn's Disease patients

  Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)

• Disease activity in Ulcerative Colitis patients

  Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)

Study Arms (2)

Letter-based transition group

ACTIVE COMPARATOR

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.

Behavioral: Letter-based transition

Combined visits-based transition

EXPERIMENTAL

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: Combined visits-based transition

Interventions

Combined visits-based transition BEHAVIORAL

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.

Combined visits-based transition

Letter-based transition BEHAVIORAL

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.

Letter-based transition group

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Written informed consent
• IBD diagnosis according to current guidelines
• Age between 16 and 19 years
• Disease in clinical remission or with mild activity

You may not qualify if:

• \- Subjects unable to provide a free and valid consent to study participation

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedale - Università Padova

Padua, PD, 35122, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 27, 2025
• Study Start: January 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)