Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 909
- 试验地点
- 1
- 主要终点
- Satisfaction
研究概览
简要总结
Inflammatory bowel diseases (IBD) is an invalidating disease mainly diagnosed in young people. The disease is characterized by a heterogenic phenotype and the disease course by flares and remissions. As in most chronic diseases the economic burden of IBD is important due to direct health care costs and disability. Health care reorganization for IBD patients in the Netherlands is necessary for several reasons. First chronic (sub)clinical mucosal inflammation results in irreversible bowel damage and complications and none of the presently available drugs is effective for all patients and many drugs have possible severe side effects. To prevent complications of the disease and side effects IBD should be monitored carefully. In the Netherlands however there is a shortage of gastroenterologists where the incidence of IBD is rising. Secondly evidence exists that direct involvement of health care workers, patient empowerment and integrated care can improve the outcome of chronic diseases. Thirdly many clinically relevant aspects (e.g. malnutrition) of this complex disease are not systematically followed in routine care. Finally the government demands registration of efficacy endpoints for expensive drugs in the near future. Therefore the investigators developed a web-based Telemedicine tool for IBD patients in collaboration with the Dutch IBD patient's organization (CCUVN). "myIBcoach" contains E-learning modules, monitors disease activity, disability, quality of life, adherence, infections, smoking status, side effects, stress and malnutrition on fixed time points with validated questionnaires, allows the patient to communicate with health care workers and gives feedback to the back office and the patient. A feasibility study in 30 IBD patients in 3 centres showed a high satisfaction and compliance of IBD-patients and health care workers with this telemedicine tool.
The aim of this study is to compare standard care for IBD patients in 3 hospitals with a care via the telemedicine tool myIBDcoach.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed IBD
- •Age 18-75 years
- •Patients who have access to internet by computer, tabloid or smartphone
排除标准
- •Not able to give informed consent
- •Not able to understand and use the Dutch language
- •In the two weeks after a hospital admission patients can not be included
结局指标
主要结局
Satisfaction
时间窗: 1 year
Questionnaire: Patient reported satisfaction with IBD care 0-10
Outpatient hospital visits
时间窗: 1 year
Amount of outpatient hospital visits between the two study-arms
次要结局
- Compliance with IBD care(1 year)
- Complications (hospital admissions)(1 year)
- Quality of care(1 year)
- Knowledge about treatment(1 Year)
- Medication Adherence(1 year)
- Disease activity(1 year)
- Smoking(1 year)
- Health care consumption(1 year)
- Self-efficacy(1 year)
- Disease specific knowledge(1 year)
- Quality of life(1 year)