Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Develop a relapse prediction model for individual patients (agreement between risk score of the individual patient and actual flares) based on both clinical parameters and biochemical parameters in the individual care pathways.
研究概览
简要总结
The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.
详细描述
The primary objective is to train and validate a relapse prediction model for individual patients available for daily (remote) care management. Besides that, risk-based care pathways for different prediction outcomes will be evaluated, prediction scores will be correlated to medication type, CRP/Calprotectin and/or endoscopy, and with known IBD clinical risk profiles. Moreover dietary intake will be correlated with the IBD risk profiles.
Study design: Multicentre, retrospective analysis of two prospective cohorts. Study population: Adult IBD patients. Main study parameters/endpoints: The endpoint will be a prediction regarding step-up or step-down in the care pathways. In other words, the percentage of patients in each individual care pathway with agreement between risk score of the individual patient and actual flares during a follow-up time of 24 months. Furthermore insight will be gained in dietary patterns amongst patients with different IBD risk profiles.
No benefits or risks are associated with participating in this study, because only standard of care is given.
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
- •Adult IBD patients
- •Subjects willing and able to sign informed consent
- •Own and are able to use a smart phone (Android or iOS)
排除标准
- •Unwilling or unable to adhere to the protocol
- •Unwilling or unable to adhere to the informed consent
- •Age <18y
结局指标
主要结局
Develop a relapse prediction model for individual patients (agreement between risk score of the individual patient and actual flares) based on both clinical parameters and biochemical parameters in the individual care pathways.
时间窗: After 2 years
This model will be based on both clinical parameters and biochemical parameters in the individual care pathways.
Validate the above mentioned prediction model and make it available for daily (remote) care management.
时间窗: After 2 years
Based on the information form the validation cohort. The model will be validated retrospectively.
次要结局
- Correlate the prediction scores of the different care pathways to medication type.(After 2 years)
- Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy(After 2 years)
- Correlate prediction scores from the algorithm with known IBD clinical risk factors(After 2 years)
- Correlate dietary intake with the assigned IBD clinical risk profiles(After 2 years)
- evaluate risk-based care pathways for different prediction outcomes in clinical practice e.g. high intensity monitoring care pathway for patients with a high prediction score.(After 2 years)
研究者
Andrea E. van der Meulen - de Jong, MD, PhD
Principal Investigator
Leiden University Medical Center