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)

Adrienn Erős, Dóra Dohos, Gábor Veres, András Tárnok, Áron Vincze, Alexandra Tészás, Noémi Zádori, Noémi Gede, Péter Hegyi, Patrícia Sarlós, Adrienn Erős, Dóra Dohos, Gábor Veres, András Tárnok, Áron Vincze, Alexandra Tészás, Noémi Zádori, Noémi Gede, Péter Hegyi, Patrícia Sarlós

Abstract

Introduction: Inflammatory bowel diseases (IBD) are among the most common chronic illnesses diagnosed in childhood. Transition from paediatric to adult care is a crucial phase. The implementation of joint visits during the transition period in IBD is widely recommended, however, strong evidence supporting their benefit is still missing. In this trial, we aim to prove the superiority of joint visits compared with usual care in improving transition outcomes of adolescents with IBD.

Methods and analysis: This is a randomised controlled two-arm multicentre trial. A minimum of 160 adolescents with IBD aged between 16.75 and 17 years will be recruited from Hungarian tertiary IBD centres. After randomisation, eligible subjects in the intervention arm attend a total of four joint visits with adult and paediatric gastroenterologist between the ages of 17 and 18. In the control arm, adolescents meet only the paediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologist 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 visits. Data will be collected at inclusion, at transfer and 12 months post-transfer. Primary outcome is the change in health-related quality of life measured with the IMPACT-III questionnaire at 1 year after transfer. Secondary outcomes include the number of patients not lost to follow-up, healthcare utilisation, disease activity, medication adherence, self-efficacy, transition readiness and patient's satisfaction. To compare the results of the two patient groups, two-sample T-test and Mann-Whitney test will be applied.

Ethics and dissemination: The Scientific and Research Ethics Committee of the Hungarian Medical Research Council approved this study (50457-2/2019/EKU). Findings will be disseminated at conferences and in medical journals.

Trial registration number: NCT04290156.

Keywords: adolescents; chronic illness; inflammatory bowel disease; quality of life, randomised controlled trial; transitional care.

Conflict of interest statement

Competing interests: None declared. Principal investigators of each study sites decline any financial and other competing interests.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the study design.

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