Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Abdominal pain scores as measured by the ESM tool.
研究概览
简要总结
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of irritable bowel syndrome according to Rome IV criteria.
- •Ability to understand and speak the national language of the concerning center.
- •Ability to understand how to utilize the ESM-tool.
排除标准
- •Any organic explanation for the abdominal complaints.
- •A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy.
- •Start up of regularly used medication from one month before inclusion until the end of study participation.
结局指标
主要结局
Abdominal pain scores as measured by the ESM tool.
时间窗: 7 days
Momentary measurements.
次要结局
- Abdominal pain scores as measured by the end-of-day diary.(7 days)
- Symptom scores (other than abdominal pain) as measured using the ESM-tool.(7 days)
- Abdominal pain scores as measured by the Gastrointestinal Symptom Rating Scale - IBS.(7 days)
- Gastrointestinal symptom scores (other than abdominal pain) as measured using the end-of-day diary.(7 days)
- Gastrointestinal symptom scores (other than abdominal pain) as measured using the GSRS-IBS.(7 days)
- Psychological symptom scores as measured using the PHQ-9.(7 days)
- Psychological symptom scores as measured using the GAD-7.(7 days)
- Quality of life scores as measured using SF-36.(7 days)