Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Subjective health and well-being
研究概览
简要总结
Swedish celiac disease women living on a gluten-free diet for years report poorer subjective health and more bowel complaints than Swedish women of same age in general population.
The investigators hypothesis is that the women participating in an education programme based on problem based learning will show higher degree of perceived health than the women receiving usual care.
详细描述
Celiac disease is a disorder of the small intestines triggered by dietary gluten, a protein in wheat-containing foods. Living with is far from easy and associated with restrictions and various dilemmas in daily life, leading to depressed mood and reduced well-being, particularly in women. We decided to include 100 celiac disease women on a gluten-free diet into a randomized controlled education trial in order to compare problem-based learning with usual care. Outcome measures will be two frequently employed questionnaires: PGWB (Psychological Well-being Index) to monitor Well-being and GSRS (Gastrointestinal Symptom Rating Scale) to measure the rate bowel symptoms as assessed at 6 months after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 yrs or above with Celiac disease treated for at least five years
排除标准
- •Anticipated inability to comply the trial protocol
结局指标
主要结局
Subjective health and well-being
时间窗: 6 months
Gastrointestinal symptoms and Psychological well-being
次要结局
- Gastrointestinal symptoms and Psychological well-being(6 months)