The aim of this study is to compare standard care for IBD patients in 4 hospitals with care via the telemedicine tool myIBDcoach.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
Difference between study arms REGARDING:
* Visits to the outpatient clinic
* Patient satisfaction with IBD health care
Secondary outcome
Secondary endpoints:
Difference between study arms REGARDING:
* Complications (hospital admissions, duration of hospital admission, need for
steroid use)
* Compliance
* Patient reported quality of care
* Medication adherence
* Self-efficacy
* Quality of life
* Knowledge about the disease and treatment
* Disease activity: amount of flares, mean relapse duration
* Consumption of healthcare
* Smoking
Background 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[1]. 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 non-of
the presently available drug is effective for all patients and many drugs have
possible severe side effects. To prevent complications of the disease and side
effect IBD should be monitored carefully. In the Netherlands however there is a
shortage of gastroenterologist 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
[2]. 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 we 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 (J. Degens. et al JCC 2014).
Study objective
The aim of this study is to compare standard care for IBD patients in 4
hospitals with care via the telemedicine tool myIBDcoach.
Study design
A two-arm, randomized controlled trial among 1000 patients visiting the
outpatient clinic of the MUMC, LUMC, Gelderse Vallei Ede, St. Antonius hospital
Nieuwegein or Orbis MC.
Intervention
Patients will be randomized between 2 arms
1. Standard-care:
2. IBD-coach arm: patients are followed with the telemedicine tool myIBDcoach
and one standard appointment after one year.
Patients in both study-arms are asked to fill-out a questionnaire at inclusion
and after one year.
Study burden and risks
Both groups will be asked to fill out a questionnaire twice.
Patients in the myIBDcoach arm can make an extra appointment to the outpatient
clinic if they feel this is warranted. They are also advised to visit the
outpatient clinic incase the healthcare worker notices an alarm signal in the
IBD-coach. Therefore there is no risk involved.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- diagnosis confirmed Crohn's disease or ulcerative colitis
- age between 18 and 75
- Patient has/can use a computer or tabloid or smart phone with a connection to the internet
Exclusion criteria
- Patients who do not speek Dutch
- Patient discharged from the hospital within 2 week prior to baseline
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47697.068.14 |
Other | volgt |