Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial (myIBDcoach)
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|ClinicalTrials.gov Identifier: NCT02173002|
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : March 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Other: myIBDcoach Other: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||909 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Active Comparator: Standard care
Other: Standard care
- Outpatient hospital visits [ Time Frame: 1 year ]Amount of outpatient hospital visits between the two study-arms
- Satisfaction [ Time Frame: 1 year ]Questionnaire: Patient reported satisfaction with IBD care 0-10
- Complications (hospital admissions) [ Time Frame: 1 year ]Hospital admission rate
- Compliance with IBD care [ Time Frame: 1 year ]
- Quality of care [ Time Frame: 1 year ]Questionnaire: patient reported quality of care 0-10
- Disease specific knowledge [ Time Frame: 1 year ]Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
- Knowledge about treatment [ Time Frame: 1 Year ]Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
- Medication Adherence [ Time Frame: 1 year ]Morisky Medication Adherence Scale
- Quality of life [ Time Frame: 1 year ]Short IBD questionnaire EQ-6D
- Disease activity [ Time Frame: 1 year ]Monitor IBD At Home score
- Smoking [ Time Frame: 1 year ]Change of smoking habits after 1 year
- Health care consumption [ Time Frame: 1 year ]Questionnaire every 3 months
- Self-efficacy [ Time Frame: 1 year ]IBD self-efficacy scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173002
|Principal Investigator:||M. Pierik, MD, PhD||Maastricht University Medical Centre|