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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-07-31

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.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

myIBDcoach

Group Type EXPERIMENTAL

myIBDcoach

Intervention Type OTHER

Interventions

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myIBDcoach

Intervention Type OTHER

Standard care

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No