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

Impact of Two TRAnsition Programs on Transition Readiness and Quality of Life in Inflammatory Bowel Disease: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease (IBD)
• Intervention / Treatment: Behavioral: Letter-based transition; Behavioral: Combined visits-based transition

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padova, PD, Italy, 35122
      • Azienda Ospedale - Università Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Letter-based transition group; 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; 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.
Experimental: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)	The PedsQL™ measures health-related quality of life in healthy children and adolescents and those with chronic conditions. It includes Physical, Emotional, Social, and School Functioning domains with scores ranging from 0-100, where higher scores indicate better quality of life.	Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Healthcare utilization	Tracking of hospitalizations, surgeries, and unplanned healthcare visits related to IBD during the transition period.	Throughout study period (Month 0 to Month 12)
Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)	The PedsQL™ measures health-related quality of life in healthy children and adolescents and those with chronic conditions. It includes Physical, Emotional, Social, and School Functioning domains with scores ranging from 0-100, where higher scores indicate better quality of life.	Baseline (T0), intermediate visit (T2), and end of transition period (T3, approximately 12 months)
Disease activity in Crohn's Disease patients	Disease activity will be measured using the Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or Harvey-Bradshaw Index (HBI) for adult patients. PCDAI scores range from 0-100 with remission defined as <10; HBI scores range from 0-25+ with remission defined as <5. For both scales, higher scores indicate more severe disease activity.	Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Disease activity in Ulcerative Colitis patients	Disease activity will be measured using the Pediatric Ulcerative Colitis Activity Index (PUCAI) for pediatric patients or partial Mayo score for adult patients. PUCAI scores range from 0-85 with remission defined as <10; partial Mayo scores range from 0-9 with remission defined as 0-1. For both scales, higher scores indicate more severe disease activity.	Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
C-reactive protein (CRP) levels	Blood concentration of CRP measured in mg/dL as an objective marker of inflammation. Normal value is <0.5 mg/dL, with higher values indicating active inflammation.	Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Fecal calprotectin levels	Concentration of fecal calprotectin measured in mg/Kg as an objective marker of intestinal inflammation. Normal value is <250 mg/Kg, with higher values indicating active intestinal inflammation.	Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
Incidence of treatment modifications	The number and type of changes in medical management (medication additions, discontinuations, or dosage adjustments) initiated during the transition period.	Throughout study period (Month 0 to Month 12)
Transition readiness perception	Visual Analog Scale (VAS) scores from patients, parents, and pediatricians assessing perception of readiness for transition. Scores range from 0-10, with higher scores indicating greater perceived readiness.	Baseline (Day 0)

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Inflammatory Bowel Disease; Transition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 5385/AO/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No