Inflammatory Bowel DiseasesNCT04254614
Mobile Application for IBD Patients With Biologics
A study testing Personalised mobile application for IBD patients in people with Inflammatory Bowel Diseases, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Personalised mobile application for IBD patients
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Mar 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory bowel disease
- Treatment with infliximab or vedolizumab
- Ability to read and understand Dutch language
Who cannot join
- Patients recently started with biologic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Personalised mobile application for IBD patients
- Keywords
- Biologic treatment, Mobile application
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised mobile application for IBD patientsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Personalised mobile application for IBD patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Overall satisfaction of care providers
We will ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10.
Measured: 6 months
Number of outpatient visits
The total number of outpatients visits in the six months before and after implementation of the application will be compared.
Measured: 6 months
Number of telephone contacts
The total number of telephone contacts in the six months before and after implementation of the application will be compared.
Measured: 6 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start12 Mar 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254614
- Sponsor's protocol ID
- NL72353.091.19
- Status last verified
- Sep 2021
- First submitted
- 13 Jan 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34448665
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application Guiding Patients With Inflammatory Bowel Disease During Biologic Treatment
- ClinicalTrials.gov ID
- NCT04254614
- Acronym / sponsor ID
- NL72353.091.19
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Biologic treatment, Mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a cohort study with assessments at baseline and after implementation of the mobile application. The study period will cover 6-12 months.
| Arm | Type | Receives |
|---|---|---|
| Personalised mobile application for IBD patients | Experimental | Device: Personalised mobile application for IBD patientsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of inflammatory bowel disease
- Treatment with infliximab or vedolizumab
- Ability to read and understand Dutch language
Key exclusion criteria (1 listed)
- Patients recently started with biologic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalised mobile application for IBD patientsPatients 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. | Device | Personalised mobile application for IBD patients |
Primary outcome
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.
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.
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.
5 secondary outcomes
Satisfaction of care providers
Time frame: 6 months
Overall satisfaction of care providers
Time frame: 6 months
Number of outpatient visits
Time frame: 6 months
Number of telephone contacts
Time frame: 6 months
Disease and treatment knowledge
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 34448665van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised mobile application for IBD patients in people with Inflammatory Bowel Diseases, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04254614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021; AzTrials last refreshed its copy on 5 Nov 2026.