Mobile Application for IBD Patients With Biologics

NCT04254614 | Completed

• 1 other identifier: NL72353.091.19
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Biologic treatment; Mobile application

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Satisfaction of care providers

  6 months

• Overall satisfaction of care providers

  6 months

• Number of outpatient visits

  6 months

• Number of telephone contacts

  6 months

• Disease and treatment knowledge

  6 months

Study Arms (1)

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.

Device: Personalised mobile application for IBD patients

Interventions

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: * 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.

Personalised mobile application for IBD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of inflammatory bowel disease
• Treatment with infliximab or vedolizumab
• Ability to read and understand Dutch language

You may not qualify if:

• Patients recently started with biologic treatment

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34448665 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 5, 2020
• Study Start: March 12, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)