NCT07159776尚未招募不适用
Multiple Digital Biomarkers for Optimization of IBD Care
Imelda GI Clinical Research Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of patients in which a flare can be detected based on passive monitoring data.
研究概览
简要总结
To develop digital biomarkers associated with disease activity of inflammatory bowel disease
详细描述
The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, grocery shopping data, patient reported outcome data, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.
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
- •Males or females aged > 18 years
- •Diagnosis of CD, UC or IBD-unspecified for at least 1 month
- •Treatment with conventional or advanced therapy for IBD at initiation of the study
- •The patient must have access to an email address
- •The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team.
- •Capacity to independently answer regular digital questionnaires
- •Capacity and willingness to use a smartphone and activity tracker
排除标准
- •Planned extended (> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time
- •Previous colectomy
- •Inability to communicate well with investigators or unable to comply with the study requirements
- •Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator)
- •Inclusion or planned inclusion in an interventional IBD-related clinical trial
结局指标
主要结局
Proportion of patients in which a flare can be detected based on passive monitoring data.
时间窗: 1 year
次要结局
- Proportion of patients in which a biomarker flare can be detected based on passive monitoring data(1 year)
- Proportion of patients in which a biomarker flare can be detected based on food purchase data(1 year)
- Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on passive monitoring(1 year)
- Proportion of patients in which a flare can be detected based on food purchase data(1 year)
- Proportion of patients in which an objective disease flare (combination of flare and biomarker flare) can be detected based on food purchase data(1 year)
研究者
研究点 (1)
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