Randomized Controlled Trial Comparing a Strategy Based on Continuous Monitoring at Home Using a Digital Remote Patient Monitoring Solution to Reference Standard in Patients With IBD Initiating an Advanced Therapy or Undergoing a Substantial Change in Their Advanced Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 主要终点
- Number of on-site IBD-related visits
研究概览
简要总结
This clinical trial aims to evaluate whether GutyCare, a digital remote patient monitoring (RPM) solution, can enhance organizational outcomes while maintaining non-inferior clinical results in patients with inflammatory bowel disease (IBD) who are initiating or undergoing significant modifications in advanced therapy.
The study compares standard care to an intervention involving the use of GutyCare, a mobile application that collects patient-reported outcomes related to symptoms.
When clinically significant symptoms are identified, alerts are transmitted to the care team, facilitating timely and personalized therapeutic adjustments.
详细描述
GutyCare is a digital medical device (dMD, CE marked, class IIa) that enables the remote monitoring of patients diagnosed with Inflammatory Bowel Disease (IBD). GutyCare is a software medical device prescribed by gastroenterologists to collect electronic patient-reported outcomes (ePRO). The workflow of GutyCare includes the following steps:
- Collection of ePRO
- Intelligent analysis and alerts
- Adapted care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before enrolment
- •Initiating an advanced therapy (i.e., biologic therapy or small molecule) OR occurrence of a substantial change in the treatment of the disease.
- •Active disease.
排除标准
- •Patients with altered intestinal continuity or function due to major abdominal surgery (e.g., stoma, extensive resection, anastomosis), uncontrolled intra-abdominal abscess, or active perianal disease.
- •Patients for whom digestive surgery is expected during the study period.
- •Patients unable or unwilling to use or already using GutyCare.
- •Vulnerable individuals as defined by French law.
研究组 & 干预措施
Control
Intervention/Treatment
干预措施: GutyCare (Device)
结局指标
主要结局
Number of on-site IBD-related visits
时间窗: 12 months
次要结局
- Clinical remission without corticosteroids(12 months)
- Patients' disease activity(12 months)
- Improvement in quality of life(12 months)