跳至主要内容
临床试验/NCT00360022
NCT00360022终止不适用

Improving the Transition of Care From Pediatric GI to Adult GI for Patients With IBD: A Prospective Randomized Trial of a New Model

Vanderbilt University Medical Center4 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
4
主要终点
Decrease IBD flare at 1 year

研究概览

简要总结

The purpose of this study is to determine if the program that has been made to ease the transition of care for adolescent patients with IBD from pediatric gastroenterology to adult gastroenterology is effective to reduce the risk of disease flare during this period. Patient satisfaction with this program will also be assessed.

详细描述

Approximately 15 to 25% of patients with inflammatory bowel disease are diagnosed prior to the age of 18. The chronic course of this disease means that approximately one quarter of all IBD patients will need to transition from being cared for by a pediatric gastroenterologist to an adult gastroenterologist. Studies in other chronic disease states have identified several problems with the current means of transitioning care from a pediatrician to the adult caregiver including lack of adherence with the proposed treatment, lack of knowledge about the disease, and limited self-care skills. Even without IBD, this can be a time of tremendous turmoil for the adolescent patient. For the chronically ill IBD patient, this stress is further intensified by the underlying illness. Several studies have shown that the risk of flare is increased by non-adherence with medical treatment. The main factors associated with poor adherence include young age and either being under the doctor's care for less than one year or being a new patient for that doctor. Therefore, young adults transferring care from a pediatric gastroenterologist to an adult gastroenterologist are at the highest risk for a bad outcome.

Several recommendations have been published on how to best transition the adolescent IBD patient from pediatric to adult care. The general consensus is that there should be a gradual age specific increase in patient autonomy and involvement in their care prior to being transitioned to an adult gastroenterologist. No study however has incorporated combined clinic visits for the patient with both the pediatric and adult IBD specialist. Furthermore, although these recommendations make logical sense, they have not been assessed objectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A patient may be considered for study participation if all of the following apply:
  • Outpatient of either sex aged ≥ 16 years or older.
  • The patient has a confirmed diagnosis of IBD.
  • No plans to move > 200 miles from Nashville in the subsequent 12 months.
  • The patient has read, understood and signed a written informed consent form. Permission of a minor participant will be obtained via a parent consent form.

排除标准

  • The patients will be excluded from the study if one or more of the following apply:
  • Unable to give consent.
  • Does not meet inclusion criteria above.

结局指标

主要结局

Decrease IBD flare at 1 year

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Schwartz

Principal Investigator

Vanderbilt University Medical Center

研究点 (4)

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