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OpenTrials
Completed

NCT Number: NCT02173002

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

myIBDcoach

Other

Standard care

Other

Primary outcomes

  1. Outpatient hospital visits

    Time frame: 1 year

    Amount of outpatient hospital visits between the two study-arms

  2. Satisfaction

    Time frame: 1 year

    Questionnaire: Patient reported satisfaction with IBD care 0-10

Secondary outcomes

  1. Complications (hospital admissions)

    Time frame: 1 year

    Hospital admission rate

  2. Compliance with IBD care

    Time frame: 1 year

  3. Quality of care

    Time frame: 1 year

    Questionnaire: patient reported quality of care 0-10

  4. Disease specific knowledge

    Time frame: 1 year

    Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?

  5. 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?

  6. Medication Adherence

    Time frame: 1 year

    Morisky Medication Adherence Scale

  7. Quality of life

    Time frame: 1 year

    Short IBD questionnaire EQ-6D

  8. Disease activity

    Time frame: 1 year

    Monitor IBD At Home score

  9. Smoking

    Time frame: 1 year

    Change of smoking habits after 1 year

  10. Health care consumption

    Time frame: 1 year

    Questionnaire every 3 months

  11. Self-efficacy

    Time frame: 1 year

    IBD self-efficacy scale

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Acronym: myIBDcoach

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2014
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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