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

Inflammatory Bowel Disease Clinical Trial

— myIBDcoach  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173002
• Other study ID #: myIBDcoach
• Status: Completed
• Phase: N/A
• First received: June 17, 2014
• Last updated: March 27, 2017
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 909
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• myIBDcoach

• Standard care

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient hospital visits	Amount of outpatient hospital visits between the two study-arms	1 year
Primary	Satisfaction	Questionnaire: Patient reported satisfaction with IBD care 0-10	1 year
Secondary	Complications (hospital admissions)	Hospital admission rate	1 year
Secondary	Compliance with IBD care		1 year
Secondary	Quality of care	Questionnaire: patient reported quality of care 0-10	1 year
Secondary	Disease specific knowledge	Questionnaire: How do you score your IBD specific knowledge on a scale from 0-10?	1 year
Secondary	Knowledge about treatment	Questionnaire: How do you score your knowledge about the medication you use on a scale from 0-10?	1 Year
Secondary	Medication Adherence	Morisky Medication Adherence Scale	1 year
Secondary	Quality of life	Short IBD questionnaire EQ-6D	1 year
Secondary	Disease activity	Monitor IBD At Home score	1 year
Secondary	Smoking	Change of smoking habits after 1 year	1 year
Secondary	Health care consumption	Questionnaire every 3 months	1 year
Secondary	Self-efficacy	IBD self-efficacy scale	1 year