Mobile Application for IBD Patients With Biologics

September 15, 2021 updated by: Rijnstate Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalised mobile application for IBD patients
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 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.
6 months
Actual use - frequency
Time Frame: 6 months
Use will be monitored with log data of the application. We will look at frequency of use of the application.
6 months
Adherence
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of care providers
Time Frame: 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.
6 months
Overall satisfaction of care providers
Time Frame: 6 months
We will ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10.
6 months
Number of outpatient visits
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL72353.091.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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