Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial (myIBDcoach)
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
myIBDcoach
Standard care
Sponsored by
About this trial
This is an interventional health services research trial for Inflammatory Bowel Disease focused on measuring Telemedicine, Patient empowerment, Integrated care
Eligibility 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
Sites / Locations
- Maastricht University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard care
myIBDcoach
Arm Description
Standard care
myIBDcoach
Outcomes
Primary Outcome Measures
Outpatient hospital visits
Amount of outpatient hospital visits between the two study-arms
Satisfaction
Questionnaire: Patient reported satisfaction with IBD care 0-10
Secondary Outcome Measures
Complications (hospital admissions)
Hospital admission rate
Compliance with IBD care
Quality of care
Questionnaire: patient reported quality of care 0-10
Disease specific knowledge
Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
Knowledge about treatment
Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
Medication Adherence
Morisky Medication Adherence Scale
Quality of life
Short IBD questionnaire EQ-6D
Disease activity
Monitor IBD At Home score
Smoking
Change of smoking habits after 1 year
Health care consumption
Questionnaire every 3 months
Self-efficacy
IBD self-efficacy scale
Full Information
NCT ID
NCT02173002
First Posted
June 17, 2014
Last Updated
March 27, 2017
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02173002
Brief Title
Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
Acronym
myIBDcoach
Official Title
Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Telemedicine, Patient empowerment, Integrated care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
909 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard care
Arm Title
myIBDcoach
Arm Type
Experimental
Arm Description
myIBDcoach
Intervention Type
Other
Intervention Name(s)
myIBDcoach
Intervention Type
Other
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
Outpatient hospital visits
Description
Amount of outpatient hospital visits between the two study-arms
Time Frame
1 year
Title
Satisfaction
Description
Questionnaire: Patient reported satisfaction with IBD care 0-10
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications (hospital admissions)
Description
Hospital admission rate
Time Frame
1 year
Title
Compliance with IBD care
Time Frame
1 year
Title
Quality of care
Description
Questionnaire: patient reported quality of care 0-10
Time Frame
1 year
Title
Disease specific knowledge
Description
Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?
Time Frame
1 year
Title
Knowledge about treatment
Description
Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?
Time Frame
1 Year
Title
Medication Adherence
Description
Morisky Medication Adherence Scale
Time Frame
1 year
Title
Quality of life
Description
Short IBD questionnaire EQ-6D
Time Frame
1 year
Title
Disease activity
Description
Monitor IBD At Home score
Time Frame
1 year
Title
Smoking
Description
Change of smoking habits after 1 year
Time Frame
1 year
Title
Health care consumption
Description
Questionnaire every 3 months
Time Frame
1 year
Title
Self-efficacy
Description
IBD self-efficacy scale
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Pierik, MD, PhD
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
32335133
Citation
de Jong MJ, Boonen A, van der Meulen-de Jong AE, Romberg-Camps MJ, van Bodegraven AA, Mahmmod N, Markus T, Dijkstra G, Winkens B, van Tubergen A, Masclee A, Jonkers DM, Pierik MJ. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1744-1752. doi: 10.1016/j.cgh.2020.04.038. Epub 2020 Apr 23.
Results Reference
derived
PubMed Identifier
28716313
Citation
de Jong MJ, van der Meulen-de Jong AE, Romberg-Camps MJ, Becx MC, Maljaars JP, Cilissen M, van Bodegraven AA, Mahmmod N, Markus T, Hameeteman WM, Dijkstra G, Masclee AA, Boonen A, Winkens B, van Tubergen A, Jonkers DM, Pierik MJ. Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial. Lancet. 2017 Sep 2;390(10098):959-968. doi: 10.1016/S0140-6736(17)31327-2. Epub 2017 Jul 14.
Results Reference
derived
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Integrated Care for Inflammatory Bowel Disease Patients in the Netherlands With the Novel Telemedicine Tool myIBDcoach: a Randomized Controlled Trial
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