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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
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Other: myIBDcoach Other: Standard care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 909 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard care
Standard care
 Other: Standard care
Experimental: myIBDcoach
myIBDcoach
 Other: myIBDcoach


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
Maastricht University
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Principal Investigator: M. Pierik, MD, PhD Maastricht University Medical Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02173002    
Other Study ID Numbers: myIBDcoach
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: September 2016
Keywords provided by Maastricht University Medical Center:
Telemedicine
Patient empowerment
Integrated care
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis