Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- External validity, questionnaire SF36
研究概览
简要总结
The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.
详细描述
Importance of measuring subjective aspects of the patient's health, often referred to as quality of life (QoL), become increasingly recognized and integrated into healthcare. For this purpose, The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for QoL assessment specific for patients who suffer from inflammatory bowel diseases. However, the IBDQ was originally developed in a cohort of Canadian patients in English language. Since QoL is impacted by underlying cultural trends, any translation of the IBDQ should be reassessed in relation to its validity, reliability, and sensitivity to detect change in the new language and cultural context. While the linguistic French translation of the original IBDQ has been validated, the French IBDQ has never been tested adequately on a French cohort of patient that we aim to perform.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women ≥ 18 years of age,
- •patient with definite diagnosis of UC or CD for at least 6 months
排除标准
- •adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
- •inability to comprehend or complete the self-administered questionnaire
- •psychiatric diagnosis that prevents participation (many pts will have anxiety or depression and should not be excluded)
- •malignancy
结局指标
主要结局
External validity, questionnaire SF36
时间窗: Day1 and Month4
Correlation with the French validated SF-36 and disease activity indexes (Harvey Bradshaw index for Crohn's disease and Simple Colitis Activity Index for ulcerative colitis, measured at the first visit and at the second visit.
Discriminant ability, disease activity indexes
时间窗: Day1 and Month4
Correlation with disease activity indexes, measured at the first visit and at the second visit.
Reliability, disease outcomes
时间窗: Day1 and Month4
Correlation with disease outcomes, measured at the first visit and at the second visit.
Internal validity, scale F-IBDQ
时间窗: Day1 and Month4
Chronbach's alpha coefficient, measured at the first visit and at the second visit.
次要结局
未报告次要终点