Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Quality of life
研究概览
简要总结
About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.
详细描述
The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.
Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.
The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
- •Must be able to participate in a education-group
排除标准
- •Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
- •Serious, untreated psychiatric disorder
结局指标
主要结局
Change in Quality of life
时间窗: 6 months
Change in Gastrointestinal symptom score
时间窗: 6 months
次要结局
- Change in health related costs(6 months)
- Evaluation of further patient needs after education(6 months)