Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Other: myIBDcoach
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed IBD Age 18-75 years Patients who have access to internet by computer, tabloid or smartphone Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Standard care | Other: Standard care<br> <br> |
| Experimental: myIBDcoach<br>myIBDcoach | Other: myIBDcoach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient hospital visits | Amount of outpatient hospital visits between the two study-arms | 1 year | 
| Satisfaction | Questionnaire: Patient reported satisfaction with IBD care 0-10 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications (hospital admissions) | Hospital admission rate | 1 year | 
| Compliance with IBD care |  | 1 year | 
| Quality of care | Questionnaire: patient reported quality of care 0-10 | 1 year | 
| Disease specific knowledge | Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10? | 1 year | 
| Knowledge about treatment | Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10? | 1 Year | 
| Medication Adherence | Morisky Medication Adherence Scale | 1 year | 
| Quality of life | Short IBD questionnaire EQ-6D | 1 year | 
| Disease activity | Monitor IBD At Home score | 1 year | 
| Smoking | Change of smoking habits after 1 year | 1 year | 
| Health care consumption | Questionnaire every 3 months | 1 year | 
| Self-efficacy | IBD self-efficacy scale | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Patient empowerment, Integrated care