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

University of Pecs

Status: Not yet enrolling

Conditions: Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Diseases

Treatments: Other: joint visits

Study type: Interventional

Funder types: Other

Identifiers

NCT04290156

50457-2/2019/EKU

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 16 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Joint visits

Experimental group

Description:

Subjects in the intervention arm attend a total of four joint transition visits performed with the participation of both the adult and the pediatric gastroenterologist.

Treatment:

Other: joint visits

Usual care

No Intervention group

Description:

Adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists with respect the patient's treatment plan.