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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Change in patient reported health-related quality of life (HRQoL) one year after transfer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the nature of the study, the blinding of the participants and personnel (pediatric and adult gastroenterologists, medical staff) is not possible, however, the blinding of the data managers and statisticians will be secured.
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
结局指标
主要结局
Change in patient reported health-related quality of life (HRQoL) one year after transfer
时间窗: 24 months
HRQoL is measured with a validated and IBD-specific questionnaire, called IMPACT III (HR) (unabbreviated scale title is not existing). It consists of 35-items, using a five-point Likert self-completed response scale. The questions are related to the severity and frequency of the following symptoms over the last two weeks: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image and treatments or interventions. The lowest score is 35, that can be achieved, and the maximum is 175 points. Higher scores indicate better HRQoL.
次要结局
- Medication adherence(24 months)
- The number of patients who needed the initiation of corticosteroid treatment(24 months)
- The number of patients who needed the initiation of biological treatment(24 months)
- Disease activity (2)(24 months)
- Laboratory parameter refers to inflammation: C-reactive protein (CRP)(24 months)
- The number of urgent imaging performed(24 months)
- Patient's satisfaction: CACHE(24 months)
- Transition readiness (2)(24 months)
- Disease activity (4)(24 months)
- Transition readiness (1)(24 months)
- Stool calprotectin level(24 months)
- Laboratory parameter refers to inflammation: White blood cell count (WBC)(24 months)
- Laboratory parameter refers to inflammation: Erythrocyte sedimentation rate (ESR)(24 months)
- The number of unplanned visits at the caregiver gastroenterologist(24 months)
- The number of urgent endoscopies performed(24 months)
- The number of patients not lost to follow-up(24 months)
- Self-efficacy: IBDSES-A(24 months)
- The number of flare-ups(24 months)
- Disease activity (1)(24 months)
- The number of scheduled endoscopies performed(24 months)
- The number of IBD related hospital admissions(24 months)
- Disease activity (3)(24 months)
- Disease activity (5)(24 months)
- The number of visits at the emergency department(24 months)
- The number of scheduled imaging performed(24 months)
- The number of IBD-related surgical interventions performed(24 months)
- The length of IBD-related hospitalization(24 months)
研究者
Sarlós Patrícia
Divison of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
University of Pecs