Study of the Psychometric Properties of Two Questionnaires for Measuring Disease Flare-up in IBD (Crohn's Disease / Hemorrhagic Rectocolitis)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08
研究概览
简要总结
Validating two questionnaires for measuring relapse in IBD (Crohn's / UC)
详细描述
IBD (Chronic Inflammatory Bowel Diseases) includes Crohn's disease and ulcerative colitis (UC). In France, an estimated 300,000 people suffer from IBD (source afa Crohn RCH France).
To our knowledge, there are no Patient Reported Outcomes (PROs) validated in French to measure the relapse phenomenon in IBD. Such an instrument would complement the available indicators and enable clinicians to detect treatment response at an early stage, as well as failure to respond to treatment, as manifested by the resumption or increased frequency of relapses, and thus enable rapid adjustment of the proposed therapeutic strategy.
Two questionnaires have been developed, their psychometric properties need to be studied.
The project's deliverable will therefore be two validated questionnaires for measuring relapse from the patient's perspective in IBD for routine use. For this reason, the questionnaires will be short, simple to use, easy to interpret and designed to integrate online applications for patient self-monitoring of IBD disease activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patient member of the AFA Crohn RCH, and registered in the mailing list
- •Person having received full information on the organization of the research and not having objected to his/her participation and to the use of his/her data.
排除标准
- •There were no non-inclusion criteria.
结局指标
主要结局
Structural validity evaluated by a confirmatory factor analysis, thresholds: comparative fit index (CFI)>0.90, Tucker-Lewis index (TLI)>0.90, root mean square error of approximation (RMSEA)<0.08
时间窗: day 0
Psychometric properties measurable in a cross-sectional study as described by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), using classical test theory and item response theory
次要结局
- Reproducibility evaluated by answers to respondents' questions according to declared status corresponding to current absence of relapse. Measured by intraclass correlation coefficient (ICC), a value above 0.70 is expected for acceptable reproducibility(day 15)
研究者
EPSTEIN Jonathan
Doctor
Central Hospital, Nancy, France