The Effect of Joint Transition Visits on Quality of Life in Inflammatory Bowel Diseases (TRANS-IBD)

The Effect of Joint Transition Visits on Quality of Life in Adolescents With Inflammatory Bowel Diseases: a Protocol for a Prospective, Randomized, Multicentre, Controlled Trial (TRANS-IBD)

Inflammatory bowel diseases (IBD) are among the most common chronic illnesses diagnosed in childhood. Moving from the pediatric to the adult health care is a crucial phase, which can greatly affect adolescents' quality of life. According to the latest international guidelines, based in particular on expert opinions, the implementation of joint visits (involving both pediatric and adult gastroenterologists) are highly recommended during the transition period. This trial aims to prove the beneficial effect of the joint visits.

Transition care is a targeted, well-planned activity, which aims to facilitate the transfer of adolescents with chronic illnesses from pediatric to adult health care. Over the past few years, several recommendations have been introduced with respect to the transitional care of adolescents with inflammatory bowel disease (IBD). According to the international recommendations, joint visits (involving both pediatric and adult gastroenterologists) are highly recommended during the transition period. Although joint visits are considered to be the most optimal form of structured transition, so far, no randomized controlled trial providing strong scientific evidence to prove the superiority of joint visits over usual care has been conducted. TRANS-IBD is a prospective, multicenter, randomized, controlled clinical trial designed to demonstrate the benefits of a structured transitional intervention involving joint visits. Patients in the intervention arm attend a total of four joint visits between the ages of 17 and 18. In the control arm, patients only meet the pediatric gastroenterologist but there is balanced consultation between the adult and the pediatric gastroenterologist, regarding the patient's medical history and treatment plan. Patients in both groups receive the same training and education, the only difference between the two arms is the presence of the adult gastroenterologist at the joint visits. The intervention period of the study starts at the age of 17 and lasts until the age of 18, when the participants are transferred to the adult gastroenterologist. The follow-up period starts from transfer and lasts until the end of the first year spent in the adult gastroenterology care.

Inclusion Criteria:

• established IBD diagnosis based on the modified "Porto Criteria" at least 6 months prior to enrolment (date of the diagnostic endoscopy)
• any form of IBD (including Crohn's disease or ulcerative colitis) regardless of disease activity and treatment
• patient aged between 16.75 and 17 years at allocation
• at least one visit attendance at the pediatric gastroenterologist in the year prior to enrolment (aiming to minimize non-adherence with the intervention)
• signed written informed consent from the legal guardian and informed assent from the patients

Exclusion Criteria:

• diagnosis of unclassified IBD (IBD-U)
• pregnancy
• medically certified developmental or intellectual disabilities (when it is expected that the patient is unable to fill the questionnaires)
• history of cancer or active cancer treatment
• BMI ≥ 40
• concomitant participation in another interventional clinical trial
• conditions when follow-up cannot be fulfilled (e.g., plan for studying or working abroad after the age of 18)