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

University of Padova

Status: Completed

Conditions: Inflammatory Bowel Disease (IBD)

Treatments: Behavioral: Letter-based transition; Behavioral: Combined visits-based transition

Study type: Interventional

Funder types: Other

Identifiers

NCT06946810

5385/AO/22

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 16 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Letter-based transition group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Letter-based transition

Combined visits-based transition

Experimental group

Description:

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.

Treatment:

Behavioral: Combined visits-based transition