Clinical trial NCT06946810: Impact of Transition Programs on Readiness and Quality of Life in IBD
Official title: Impact of Two TRAnsition Programs on Transition Readiness and Quality of Life in Inflammatory Bowel Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease (IBD)
Keywords: Transition
Pediatric
Inflammatory Bowel Disease
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 41
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Transition readiness as measured by the Transition Readiness Assessment Questionnaire (TRAQ)
timeFrame: Baseline and at end of transition period (approximately 12 months)
Secondary outcomes:
measure: Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)
timeFrame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
measure: Healthcare utilization
timeFrame: Throughout study period (Month 0 to Month 12)
measure: Quality of life as measured by the Pediatric Quality of Life Inventory™ (PedsQL™)
timeFrame: Baseline (T0), intermediate visit (T2), and end of transition period (T3, approximately 12 months)
measure: Disease activity in Crohn's Disease patients
timeFrame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
measure: Disease activity in Ulcerative Colitis patients
timeFrame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
measure: C-reactive protein (CRP) levels
timeFrame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
measure: Fecal calprotectin levels
timeFrame: Baseline (Day 0), intermediate visit (Month 6), and end of transition period (Month 12)
measure: Incidence of treatment modifications
timeFrame: Throughout study period (Month 0 to Month 12)
measure: Transition readiness perception
timeFrame: Baseline (Day 0)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedale - Università Padova
state: PD
Study officials:
References: