Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalised mobile application for IBD patients | Experimental | This is a cohort study with a 1 arm intervention group, without a control group. Patients included in this study will be invited to use a mobile application. The content and functionalities of this application are described in the intervention section. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalised mobile application for IBD patients | Device | Patients will use a mobile application for ±6months (exact period depends on interval of biologic treatment) with the following functionalities:
Patients will fill in a questionnaire to measure study outcomes at baseline and at the end of the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | 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. | 6 months |
| Actual use - frequency | Use will be monitored with log data of the application. We will look at frequency of use of the application. | 6 months |
| Adherence | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of care providers | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34448665 | Derived | van Erp LW, Groenen MJM, Heida W, Wisse J, Roosenboom B, Wahab PJ. Mobile application to monitor inflammatory bowel disease patients on intravenous biologic treatment: a feasibility study. Scand J Gastroenterol. 2021 Dec;56(12):1414-1421. doi: 10.1080/00365521.2021.1966832. Epub 2021 Aug 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
Not provided
Not provided
Not provided
Not provided
|
| 6 months |
| Overall satisfaction of care providers | We will ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10. | 6 months |
| Number of outpatient visits | The total number of outpatients visits in the six months before and after implementation of the application will be compared. | 6 months |
| Number of telephone contacts | The total number of telephone contacts in the six months before and after implementation of the application will be compared. | 6 months |
| Disease and treatment knowledge | 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). | 6 months |