Erős Adrienn, Dohos Dóra, Veres Gábor, Tárnok András, Vincze Áron, Tészás Alexandra, Zádori Noémi, Gede Noémi, Hegyi Péter, Sarlós Patrícia
Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary.
Heim Pál Children's Hospital, Budapest, Hungary, Budapest, Hungary.
BMJ Open. 2020 Oct 6;10(10):e038410. doi: 10.1136/bmjopen-2020-038410.
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.
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.
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.
NCT04290156.
炎症性肠病（IBD）是儿童期诊断出的最常见慢性病之一。从儿科护理过渡到成人护理是一个关键阶段。广泛推荐在IBD的过渡期进行联合问诊，然而，仍缺乏支持其益处的有力证据。在本试验中，我们旨在证明与常规护理相比，联合问诊在改善IBD青少年过渡结局方面的优越性。
这是一项双臂随机对照多中心试验。将从匈牙利三级IBD中心招募至少160名年龄在16.75至17岁之间的IBD青少年。随机分组后，干预组符合条件的受试者在17至18岁期间与成人及儿科胃肠病学家共进行四次联合问诊。在对照组中，青少年仅与儿科胃肠病学家会面，但两位胃肠病学家会就患者的治疗方案进行均衡的会诊。两组患者接受相同的培训和教育，两组之间唯一的决定性差异是联合问诊时成人胃肠病学家的在场情况。将在入组时、转诊时和转诊后12个月收集数据。主要结局是转诊后1年使用IMPACT-III问卷测量的健康相关生活质量的变化。次要结局包括未失访的患者数量、医疗保健利用情况、疾病活动度、药物依从性、自我效能感、过渡准备情况和患者满意度。为比较两组患者的结果，将应用两样本T检验和曼-惠特尼检验。
匈牙利医学研究理事会科学与研究伦理委员会批准了本研究（50457-2/2019/EKU）。研究结果将在会议和医学期刊上发表。
NCT04290156。
