Mobile Application for IBD Patients With Biologics

NCT ID: NCT04254614

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2021-02-01

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Personalised mobile application for IBD patients

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 34448665 (View on PubMed)

Other Identifiers

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NL72353.091.19

Identifier Type: -

Identifier Source: org_study_id

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