Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02173002
Acronym
myIBDcoach
Enrollment
909
Registered
2014-06-24
Start date
2014-07-31
Completion date
2016-07-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

Telemedicine, Patient empowerment, Integrated care

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.

Interventions

OTHERmyIBDcoach
OTHERStandard care

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Outpatient hospital visits1 yearAmount of outpatient hospital visits between the two study-arms
Satisfaction1 yearQuestionnaire: Patient reported satisfaction with IBD care 0-10

Secondary

MeasureTime frameDescription
Compliance with IBD care1 year
Quality of care1 yearQuestionnaire: patient reported quality of care 0-10
Knowledge about treatment1 YearQuestionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
Medication Adherence1 yearMorisky Medication Adherence Scale
Disease specific knowledge1 yearQuestionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
Disease activity1 yearMonitor IBD At Home score
Smoking1 yearChange of smoking habits after 1 year
Health care consumption1 yearQuestionnaire every 3 months
Self-efficacy1 yearIBD self-efficacy scale
Quality of life1 yearShort IBD questionnaire EQ-6D
Complications (hospital admissions)1 yearHospital admission rate

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026