Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
- Conditions
- Inflammatory Bowel Disease
- Interventions
- Other: Standard careOther: myIBDcoach
- Registration Number
- NCT02173002
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 909
- Diagnosed IBD
- Age 18-75 years
- Patients who have access to internet by computer, tabloid or smartphone
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care Standard care Standard care myIBDcoach myIBDcoach myIBDcoach
- Primary Outcome Measures
Name Time Method Satisfaction 1 year Questionnaire: Patient reported satisfaction with IBD care 0-10
Outpatient hospital visits 1 year Amount of outpatient hospital visits between the two study-arms
- Secondary Outcome Measures
Name Time Method Complications (hospital admissions) 1 year Hospital admission rate
Quality of care 1 year Questionnaire: patient reported quality of care 0-10
Knowledge about treatment 1 Year Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
Medication Adherence 1 year Morisky Medication Adherence Scale
Disease activity 1 year Monitor IBD At Home score
Smoking 1 year Change of smoking habits after 1 year
Health care consumption 1 year Questionnaire every 3 months
Self-efficacy 1 year IBD self-efficacy scale
Disease specific knowledge 1 year Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
Quality of life 1 year Short IBD questionnaire EQ-6D
Compliance with IBD care 1 year
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Netherlands