Inflammatory Bowel Diseases
Conditions
Keywords
Biologic treatment, Mobile application
Brief summary
Monitoring of biologic treatment in patients with inflammatory bowel disease (IBD) is important given the increased risk of infections. In this study we aim to evaluate the use of a mobile application to guide IBD patients and facilitate the monitoring of biologic treatment.
Detailed description
Biologic treatment 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 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. In this study we aim to evaluate the use of a mobile application to guide IBD patients during biologic treatment. Adult patients with diagnosis of IBD treated with biologics will be included. The mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.
Interventions
DEVICEPersonalised mobile application for IBD patients
Patients will use a mobile application for ±6months (exact period depends on interval of biologic treatment) with the following functionalities: * Personal interactive timeline to prepare for biologic treatment with reminders for blood tests, a questionnaire to exclude contra-indications for biologic treatment (e.g. current infection) and a message from the gastroenterology nurse when blood tests results and the questionnaire have been checked. Only in case of abnormal results or answers patients will be contacted by telephone by their gastroenterology nurse, which is currently standard care. * Information about the patients' diagnosis and biologic treatment. * General information on e.g. IBD treatment, vaccinations, frequently used medical terms, preparing for outpatient visits, what to do in case of disease symptoms. Patients will fill in a questionnaire to measure study outcomes at baseline and at the end of the study period.
Sponsors
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of inflammatory bowel disease * Treatment with infliximab or vedolizumab * Ability to read and understand Dutch language
Exclusion criteria
* Patients recently started with biologic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 months | All patients will be asked to complete questions about satisfaction with the mobile application, the information in the app and the user-friendliness of the app. This will be measured with a 7-point likert scale after using the application for ± 6 months. We will also ask patients about their overall satisfaction of care before and after implementation of the application using a visual analogue scale (VAS) scale 0 - 10. |
| Actual use - frequency | 6 months | Use will be monitored with log data of the application. We will look at frequency of use of the application. |
| Adherence | 6 months | The adherence of patients to reminders will be evaluated by checking time of blood tests as recorded in the electronic medical record and log data from administered questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of telephone contacts | 6 months | The total number of telephone contacts in the six months before and after implementation of the application will be compared. |
| Satisfaction of care providers | 6 months | After ± 6 months, health care professionals will be asked to fill in a questionnaire to measure their experiences with the application, experience with monitoring the questionnaire, satisfaction, organizational advantages/disadvantages for example time investment, efficiency of work processes. This will be measured with a 7-point likert scale after using the application for ± 6 months. We will also ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10. |
| Disease and treatment knowledge | 6 months | The knowledge of disease and its treatment of patients before and after implementation of the application will be compared and assessed using a VAS Scale (scale 0 - 10). |
| Overall satisfaction of care providers | 6 months | We will ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10. |
| Number of outpatient visits | 6 months | The total number of outpatients visits in the six months before and after implementation of the application will be compared. |
Countries
Netherlands
Outcome results
None listed