In this study we aim to evaluate the feasibility of a mobile application guiding IBD patients during biologic treatment.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primarily, we will evaluate the satisfaction of patients with the mobile
application, actual use and adherence.
Secondary outcome
The satisfaction of care providers and change in number of outpatient visits
and telephone contacts will also be evaluated.
Background summary
Biologic treatment, including infliximab and vedoluzimab, can induce and
maintain remission in patients with inflammatory bowel disease (IBD). However,
biologics are associated with increased risk of infections. Therefore, it is
important to regularly monitor patients for infections during the course of
therapy. This process can be time consuming for patients as well as clinicians.
Mobile applications, have the potential to guide patients and facilitate
monitoring of biologic treatment.
Study objective
In this study we aim to evaluate the feasibility of a mobile application
guiding IBD patients during biologic treatment.
Study design
This is a feasibility study with assessments at baseline and after
implementation of the mobile application. The study period will cover 6-12
months.
Intervention
Patients will use a mobile application to guide them during biologic treatment.
The mobile application consists of the following functionalities:
* A personal timeline consisting of information, reminders and a questionnaire
with feedback from the gastroenterology nurse to prepare for next biologic
treatment.
* Information about the patients* disease and treatment.
* General information modules, for example about vaccinations and medical
terms.
* Information to provide patients with tools to decide when and how to consult
their care-giver if they experience possible change in disease complaints.
Study burden and risks
We believe patients will benefit from using the mobile application. It has the
potential to save time for patients as well as clinicians, previously spend on
telephone contact between the gastroenterology nurse and patient to discuss a
simple checklist to check for infections. Also, patients will be guided via
reminders, for example when blood tests are needed. We believe risks are
negligible. The results of blood tests and answers to questionnaire filled in
via the application are checked manually for each patient by an experienced
gastroenterology nurse. If there is any doubt about results obtained via the
application, patients will be contacted by telephone as is standard care.
Lastly, the requested time investment of patients is limited, with a short
questionnaire (± 10 minutes) prior to implementing the application and after ±
6 six months.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of inflammatory bowel disease (including Crohn*s disease,
ulcerative colitis and IBD-unclassified) based on a combination of clinical,
endoscopic, histologic and radiologic internationally accepted criteria.
- Treatment with biologics, for the purpose of this study only patients with
biologics that are administered intravenously in the hospital every 4-10 weeks
are included (infliximab or vedoluzimab).
- Aged 18 years or older.
- Having (access to) a tablet or smartphone.
- Having (access to) working internet connection.
- Ability to read and understand the Dutch language.
Exclusion criteria
- Patients recently started with biologic treatment (< 3 maanden)
- No access to a tablet or smartphone
- No internet access
Design
Recruitment
Medical products/devices used
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 | NL72353.091.19 |