Is Relapse Rate Reduced by Home Monitoring of IBD Patients Tightly or on Demand by FC and Disease Activity?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total Inflammation Burden Scoring ( TIBS)
研究概览
简要总结
The purpose of this study is to determine if the IBD patient doing home monitoring by web app's for disease activity (DA) and fecal calprotectin (FC) on demand (OD), compared with patients doing home monitoring scheduled interval combined with "on demand"(SI+OD) ( every 3.month).
Will home monitoring of DA and FC OD vs SI+OD reduce frequency of relapse in one year follow up? Is the frequent FC measurement in SI+OD test group predictive of an early recognition of relapse, and thus help change the naturel course of disease? Will home monitoring of DA and FC in OD vs SI+OD change the course of the disease in terms of disease activity, spread of the disease, hospitalizations and number of hospitalization days, required surgery and outpatient visits? Is there a difference in patients' compliance with treatment plan between OD vs SI+OD ? Is there difference in patients-adherence between OD vs SI+OD ?
详细描述
Detailed Description Among 2.500 IBD patients the investigators will consecutively from the Gastroenterology out-patient clinic at North Zealand University Hospital recruit in total 120 in the study.
At the out-patient consultation IBD patients will be informed about the project and the IBD eHealth nurse ensures that no exclusion criteria met by the patient.
Inclusion criteria: IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16) IBD patients who can read, speak and understand Danish IBD patients that can take advantage of the Internet and wireless network 18years or older.
Exclusion criteria: IBD patients with severe disease activity HB > 16 SCCAI ≥ 5 ) IBD patients with social, medical or psychological issues of a more complex character IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
IBD patients who cannot attend due language barrier or cognitive disorder. Age less 18. When the patient has agreed to participate in the study, randomized to either OD or SI OD 3. Months (SI group):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI < 5 (Harvey & Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI < 16)
- •IBD patients who can read, speak and understand Danish
- •IBD patients that can take advantage of the Internet and wireless network 18 years or older
排除标准
- •IBD patients with severe disease activity ( HB > 16 SCCAI ≥ 5 )
- •IBD patients with social, medical or psychological issues of a more complex character
- •IBD patients with particularly complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
- •IBD patients who cannot attend due language barrier or cognitive disorder.
- •When the patient has agreed to participate in the study
研究组 & 干预措施
Scheduled (SI)
"Scheduled" means screening every 3rd month ( home FC and DA) plus when needed and upgrade of ususal treatment
干预措施: SI (Other)
On Demand (OD)
On "Demand" means screening of home FC and DA when the patients feel for it and upgrade of usual treatment
干预措施: OD (Other)
结局指标
主要结局
Total Inflammation Burden Scoring ( TIBS)
时间窗: 1 year
The outcome measure of TIBS (FC ( ELISA Smartphone test)and Disease Activity ( Simple Clical Colitis Activity Index or Harvey-Bradshaw Index) has been chosen as endpoint for comparing the two screening methods in relation to relapse rate
次要结局
未报告次要终点