Clinical trial NCT04290156: The Effect of Joint Transition Visits on Quality of Life in Inflammatory Bowel Diseases (TRANS-IBD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn's Disease
Ulcerative Colitis
Keywords: inflammatory bowel disease
transitional care
adolescents
chronic illness
quality of life
randomized controlled trial
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, two-arm, multicentre trial. The target patient population consists of adolescents with inflammatory bowel diseases (IBD), aged between 16.75 and 17 years. The sample size calculation suggests that 160 subjects (80/ each arm) is required. The allocation ratio is 1:1. Eligible participants in the intervention arm attend a total of four joint transition visits with the adult and the pediatric gastroenterologist. In the control arm, adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists regarding the patient's treatment plan. Patients in both groups receive the same training and education, the only determinative difference between the two arms is the presence of the adult gastroenterologist at the joint transition visits.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in patient reported health-related quality of life (HRQoL) one year after transfer
timeFrame: 24 months
Secondary outcomes:
measure: The number of patients not lost to follow-up
timeFrame: 24 months
measure: Medication adherence
timeFrame: 24 months
measure: Self-efficacy: IBDSES-A
timeFrame: 24 months
measure: Patient's satisfaction: CACHE
timeFrame: 24 months
measure: Transition readiness (1)
timeFrame: 24 months
measure: Transition readiness (2)
timeFrame: 24 months
measure: The number of flare-ups
timeFrame: 24 months
measure: The number of patients who needed the initiation of corticosteroid treatment
timeFrame: 24 months
measure: The number of patients who needed the initiation of biological treatment
timeFrame: 24 months
measure: Stool calprotectin level
timeFrame: 24 months
measure: Disease activity (1)
timeFrame: 24 months
measure: Disease activity (2)
timeFrame: 24 months
measure: Disease activity (3)
timeFrame: 24 months
measure: Disease activity (4)
timeFrame: 24 months
measure: Disease activity (5)
timeFrame: 24 months
measure: Laboratory parameter refers to inflammation: C-reactive protein (CRP)
timeFrame: 24 months
measure: Laboratory parameter refers to inflammation: White blood cell count (WBC)
timeFrame: 24 months
measure: Laboratory parameter refers to inflammation: Erythrocyte sedimentation rate (ESR)
timeFrame: 24 months
measure: The number of unplanned visits at the caregiver gastroenterologist
timeFrame: 24 months
measure: The number of visits at the emergency department
timeFrame: 24 months
measure: The number of scheduled imaging performed
timeFrame: 24 months
measure: The number of urgent imaging performed
timeFrame: 24 months
measure: The number of scheduled endoscopies performed
timeFrame: 24 months
measure: The number of urgent endoscopies performed
timeFrame: 24 months
measure: The number of IBD-related surgical interventions performed
timeFrame: 24 months
measure: The number of IBD related hospital admissions
timeFrame: 24 months
measure: The length of IBD-related hospitalization
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Insitute for Translational Medicine, University of Pécs, HU
name: Péter Hegyi, MD, PhD, DSc
role: STUDY_CHAIR
affiliation: First Department of Medicine, University of Pécs, Medical School, Pécs, Hungary
name: Patrícia Sarlós, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brooks AJ, Smith PJ, Cohen R, Collins P, Douds A, Forbes V, Gaya DR, Johnston BT, McKiernan PJ, Murray CD, Sebastian S, Smith M, Whitley L, Williams L, Russell RK, McCartney SA, Lindsay JO. UK guideline on transition of adolescent and young persons with chronic digestive diseases from paediatric to adult care. Gut. 2017 Jun;66(6):988-1000. doi: 10.1136/gutjnl-2016-313000. Epub 2017 Feb 21.
citation: van Rheenen PF, Aloi M, Biron IA, Carlsen K, Cooney R, Cucchiara S, Cullen G, Escher JC, Kierkus J, Lindsay JO, Roma E, Russell RK, Sieczkowska-Golub J, Harbord M. European Crohn's and Colitis Organisation Topical Review on Transitional Care in Inflammatory Bowel Disease. J Crohns Colitis. 2017 Sep 1;11(9):1032-1038. doi: 10.1093/ecco-jcc/jjx010.
citation: Suris JC, Akre C. Key elements for, and indicators of, a successful transition: an international Delphi study. J Adolesc Health. 2015 Jun;56(6):612-8. doi: 10.1016/j.jadohealth.2015.02.007.
citation: Fair C, Cuttance J, Sharma N, Maslow G, Wiener L, Betz C, Porter J, McLaughlin S, Gilleland-Marchak J, Renwick A, Naranjo D, Jan S, Javalkar K, Ferris M; International and Interdisciplinary Health Care Transition Research Consortium. International and Interdisciplinary Identification of Health Care Transition Outcomes. JAMA Pediatr. 2016 Mar;170(3):205-11. doi: 10.1001/jamapediatrics.2015.3168.
citation: van den Brink G, van Gaalen MAC, de Ridder L, van der Woude CJ, Escher JC. Health Care Transition Outcomes in Inflammatory Bowel Disease: A Multinational Delphi Study. J Crohns Colitis. 2019 Sep 19;13(9):1163-1172. doi: 10.1093/ecco-jcc/jjz044.
citation: Eros A, Soos A, Hegyi P, Szakacs Z, Eross B, Parniczky A, Mezosi E, Rumbus Z, Sarlos P. Spotlight on Transition in Patients With Inflammatory Bowel Disease: A Systematic Review. Inflamm Bowel Dis. 2020 Feb 11;26(3):331-346. doi: 10.1093/ibd/izz173.
citation: Eros A, Dohos D, Veres G, Tarnok A, Vincze A, Teszas A, Zadori N, Gede N, Hegyi P, Sarlos P. Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD). BMJ Open. 2020 Oct 6;10(10):e038410. doi: 10.1136/bmjopen-2020-038410.