Mobile Application for IBD Patients With Biologics

Inflammatory Bowel Diseases Clinical Trial

Official title:

A Mobile Application Guiding Patients With Inflammatory Bowel Disease During Biologic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254614
• Other study ID #: NL72353.091.19
• Status: Completed
• Phase: N/A
• Start date: March 12, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2021
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• Personalised 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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