NCT02550158已完成不适用
A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives35 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 35
- 主要终点
- Psycho-pedagogic score (ECIPE score)
研究概览
简要总结
This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Male or female patients 18 -70 years of age
- •Recent diagnosis (less than 6 months) of Crohn's Disease or ulcerative colitis OR patients with an oldest pathology with a new flare, a complication and / or need to optimize medical therapy
排除标准
- •Patients unable to understand and follow the program
结局指标
主要结局
Psycho-pedagogic score (ECIPE score)
时间窗: 6 months after Inclusion
Variation of a psycho-pedagogic score (ECIPE score) measured at baseline and 6 months after inclusion.
次要结局
- Disease Flare(6 months after inclusion)
- Quality of life(6 months after inclusion)
- Patient concerns(6 months after inclusion)
- Observance(6 months after inclusion)
- Hospitalization(6 months after inclusion)
- Major complication(6 months after inclusion)
- Work productivity(6 months after inclusion)
研究者
研究点 (35)
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