An interventional study of myIBDcoach and Standard care in Inflammatory Bowel Disease, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-28.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Health services research
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.
964 studies on the registry are indexed under Intestinal Diseases; 176 are open to participants now.
This study's enrollment of 909 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard care
Other: Standard care
myIBDcoach
Other: myIBDcoach
Outpatient hospital visits
Amount of outpatient hospital visits between the two study-arms
Time frame: 1 year
Satisfaction
Questionnaire: Patient reported satisfaction with IBD care 0-10
Time frame: 1 year
Complications (hospital admissions)
Hospital admission rate
Time frame: 1 year
Compliance with IBD care
Time frame: 1 year
Quality of care
Questionnaire: patient reported quality of care 0-10
Time frame: 1 year
Disease specific knowledge
Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
Time frame: 1 year
Knowledge about treatment
Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
Time frame: 1 Year
Medication Adherence
Morisky Medication Adherence Scale
Time frame: 1 year
Quality of life
Short IBD questionnaire EQ-6D
Time frame: 1 year
Disease activity
Monitor IBD At Home score
Time frame: 1 year
Smoking
Change of smoking habits after 1 year
Time frame: 1 year
Health care consumption
Questionnaire every 3 months
Time frame: 1 year
Self-efficacy
IBD self-efficacy scale
Time frame: 1 year
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center