Mobile Application for IBD Patients With Biologics

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases

• Registration Number: NCT04254614
• Lead Sponsor: Rijnstate Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-03-12
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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 telephone contacts	6 months	The total number of telephone contacts in the six months before and after implementation of the application will be compared.
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.
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).

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands