Impact of the Diagnosis of Celiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 1
- 主要终点
- Psychological General Well-Being (PGWB) Index
研究概览
简要总结
The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.
详细描述
All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis within one year
- •biopsy-proven diagnosis
排除标准
- •Celiac disease diagnosis previously than within one year
- •No biopsy-proven diagnosis
结局指标
主要结局
Psychological General Well-Being (PGWB) Index
时间窗: 5 years
Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
次要结局
- healthcare resource utilization(5 years)
- Gastrointestinal Symptoms Rating Scale (GSRS)(5 years)
- dietary compliance(5 years)
- weight(5 years)
- height(5 years)
- The Short Form (SF-36) Health Survey(5 years)
研究者
Kalle Kurppa
M.D, pH.D, Pediatrician
Tampere University Hospital