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

NCT ID: NCT06946810

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-30

Brief Summary

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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 Inventoryâ„¢), 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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease (IBD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Letter-based transition

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Combined visits-based transition

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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ZINGONE FABIANA

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedale - Università Padova

Padua, PD, Italy

Site Status

Countries

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Italy

Other Identifiers

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5385/AO/22

Identifier Type: -

Identifier Source: org_study_id

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