Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Percentage of cumulative time spent in symptomatic remission within 12 months
研究概览
简要总结
Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.
We propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.
详细描述
Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.
We propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.
Main objective: To evaluate whether tight control through remote monitoring device improves disease activity compare to standard of care in patients with active Inflammatory Bowel Disease (IBD).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD/UC patients with a validated diagnosis
- •Patients age > 18 years
- •IBD with clinical signs of PRO2 activity leading to modification of medical treatment: introduction of a new treatment, or change of dose or addition of a treatment (corticoids, ASA, IS, biotherapy (a 4 week induction phase is authorized
- •Patients willing and able to participate in the collection of data via SEMEIA App on their smartphone
- •Patients agreeing to participate for 12 months
排除标准
- •Patients with an inability to use a smartphone and email
- •Patients < 18 years old
- •Digestive surgery expected within 3 months
- •Pregnancy at baseline
- •Patients with an history of sub-total colectomy, coloproctectomy, digestive ostomy, extensive or multiple intestinal resections with sequelae of diarrhoea, short bowel syndrome.
- •Patients who have had recent digestive surgery (ileal resection < 6 months) Patients with any other uncontrolled somatic or psychiatric pathology
- •Patients enrolled in a trial with an investigational treatment
结局指标
主要结局
Percentage of cumulative time spent in symptomatic remission within 12 months
时间窗: 12 months
Percentage of cumulative time spent in symptomatic remission within 12 months Time spent in symptomatic remission defined by (PRO2): MC: abdominal pain ≤ 1 and stool frequency ≤ 3 defined clinical remission in CD, both not worsening compared from inclusion UC: absence of rectal bleeding (score 0) and stool frequency score ≤ 1, both not worsening compared with inclusion
次要结局
- Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)(12 months)
- Average value of IBD disk change from baseline over 12 months(12 months)
- Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12(6 and 12 months)
- Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.)(12 months)
- Average value of Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.) change from baseline over 12 months(12 months)
- Number of contacts / consultations / hospitalizations during 12 months(12 months)
- Medication and care compliance/consumption over 12 months(12 months)
- number of complications (AE/SAE, hospitalizations, surgeries) over 12 months(12 months)
- Satisfaction questionnaires (patients/care team) at M12(12 months)
- Average value of IBD disk change from baseline over 12 months(12 months)
- Number of contacts / consultations / hospitalizations during 12 months(12 months)
- Medication and care compliance/consumption over 12 months(12 months)
- number of complications (AE/SAE, hospitalizations, surgeries) over 12 months(12 months)
- Satisfaction questionnaires (patients/care team) at M12(12 months)