Tailored Re-evaluation for Adolescents With Inflammatory Bowel Disease in Transition (TRANSIT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process
研究概览
简要总结
Background: Smooth transition of adolescent patients diagnosed with inflammatory bowel diseases (IBD) to adult care is necessary in order to secure continues clinical management and to prevent possible deleterious clinical and psychosocial implications. In recent years there is an emphasis on successful transition, however, there are no standardized models or consensus guidelines incorporating both clinical and psychosocial aspects of transition. Objectives: To examine the effect a comprehensive clinical and psychosocial transition package on clinical management and patients outcomes in adolescents with IBD. Design: A prospective, trans-sectional study. Setting: The Schneider Children's Medical Center and the Rabin Medical Center. Participants: Children 17 year to 18 years who are diagnosed with IBD and are planned to initiate transition process to adult care. Main outcome measures: Change in clinical management as a result of tailored re-evaluation as a part of tailored transition package. Secondary outcome measures: a. The effect of a tailored transition package on patients' self-efficacy perception and readiness for transition. b. The effect of a tailored transition package on patient's outcomes (disease activity, flares, hospitalizations) during the first year following transition.
详细描述
General intervention scheme:
Patients with an established diagnosis of IBD (crohn's disease, ulcerative colitis or IBD-unclassified) will be enrolled between the age of 17 and 17.5 years. Patients are eligible for enrollment 6 months following diagnosis and onward.
Following enrollment each patient will undergo a structured re-evaluation as follows:
Each patient will be thoroughly examined and have height ,weight, body mass index performed as well as comprehensive laboratory examinations. Fecal sample for fecal calprotectin will be obtained as well. Extent of disease will be registered using the Montreal classification. Disease activity indices will be calculated according to the Harvey-Bradshaw Index (HBI) for crohn's and Partial Mayo Score (PMS) for UC.
Serum of patients treated with biologic medications will be analyzed for drug trough levels and anti-drug antibodies. Patients treated with thiopurines will have their blood analyzed for thiopurines metabolites. Patients will complete a "self-efficacy" and Transition Readiness Assessment Questionnaire (TRAQ). Both questionnaires were linguistically validated by bi-directional translation. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy. Flexible sigmoidoscopy was recently shown to have a high degree of correlation with complete colonoscopy in assessments of UC activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of inflammatory bowel disease
- •Age: 17 - 18 years ( inclusive)
- •Informed consent
排除标准
- •1. Recent diagnosis (last 6 months)
结局指标
主要结局
Change in therapeutic regimen as a result tailored clinical re-evaluation at the end of the transition process
时间窗: 6 months following enrollment
次要结局
- The rate of flares during the first year following transition(12 months following transition)
- Disease activity (evaluated by crohn's disease activity index for crohn's and Mayo Clinic Index of Activity for UC) at 12 months following transition(12 months following transition)
- The change in "self-efficacy" score at the end of the transition process(6 months following enrollment)
- The rate of hospitalizations during the first year following transition(12 months following transition)
- Surgical rate during the first year following transition(12 months following transition)
研究者
Amit Assa
Head of IBD program
Schneider Children's Medical Center, Israel