Inflammatory Bowel DiseasesMEDICATIONNCT05321485
The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD
A study testing MedicijnWijs in people with Inflammatory Bowel Diseases and Crohn Disease, run by Maxima Medical Center at 3 sites in Netherlands.
Trial summary
Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- MedicijnWijs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesNetherlands
- Study dates
- 16 Mar 2022to 16 Sep 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 12 up to and including 17 years old
- Condition: IBD (Crohn's Disease and Ulcerative Colitis)
- Treatment: azathioprine
Who cannot join
- Inability to use MedicijnWijs due to either low cognitive skills or the unavailability of a phone or other technical device to use the app on
Trial locations and contacts
3 sites in 1 country.
Luc JJ Derijks, PharmD, PhD contact
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Catharina Hospital
Eindhoven, North Brabant, 5623EJ
Janneke M Stapelbroek, MD, PhD, janneke.stapelbroek@catharinaziekenhuis.nl
Inge GPT Sauvé-van Gorp
- Not yet recruiting
Zuyderland Medisch Centrum
Heerlen, North Brabant, 6419PC
Nanja Bevers, MD, n.bevers@zuyderland.nl
Nanja Bevers, MD
- Recruiting
Maxima Medical Center
Veldhoven, North Brabant, 5500VB
Kaylee Stabel, BSc, +31629161384, kaylee.stabel@mmc.nl
Luc JJ Derijks, PharmD, PhD, l.derijks@mmc.nl
About this study
Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. It provides information about IBD and azathioprine. In this multicenter before-and-after study, the aim is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. This is done using two validated questionnaires that are translated to Dutch: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. These questionnaires are filled in at the beginning of the study period and after 6 weeks of using MedicijnWijs. This way a change in both scores can be assessed. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.
Read the detailed description
Rationale: medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. The aim of this study is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.
Objective: with this study, the effect of the mobile phone app MedicijnWijs on adherence to azathioprine therapy will be assessed. In addition, the effect on knowledge about IBD and the ease of use of MedicijnWijs will be studied as well.
Study design: this study is a multicenter before-and-after study. Study population: the study population are adolescents aged 12 up to and including 17 years old. All participants are diagnosed with IBD and are treated with azathioprine. This multicenter study will be conducted in Máxima Medical Center in Veldhoven, Catharina Hospital in Eindhoven, and Zuyderland Medical Center in Sittard-Geleen/Heerlen, The Netherlands.
Intervention: the participants will use the mobile phone app MedicijnWijs for 6 weeks. In this app, information about IBD and azathioprine is provided. Participants also receive questions about their symptoms through the app. Moreover, at the beginning of the study the participants have to fill in two validated questionnaires that are translated to Dutch in the app: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. After 6 weeks, the participants have to fill out the same questionnaires again to assess potential changes in the scores compared to baseline. Also, a number of questions will be asked to assess the ease of use of MedicijnWijs.
Main study parameters/endpoints: the main endpoint is change in adherence to azathioprine therapy measured as a change in MARS-5 score. In addition, the secondary endpoint change in knowledge about IBD measured as a change in IBD-KID2 score will be studied as well. The results of the secondary endpoint ease of use of MedicijnWijs will be presented descriptively.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: there are no risks associated with participation to this study as participants only have to use a mobile phone app and fill in two short questionnaires. MedicijnWijs has to be used for 6 weeks. The time burden per day varies from 0 to 10 minutes. The IBD treatment of the participants will not change, and participants will visit their doctors as frequently as usual. Only an additional introductory talk will be necessary, which will be scheduled during a regular outpatient clinic visit. No physical examinations, blood tests, or other tests will be done during this study apart from routine care of IBD.
- Being tested
- MedicijnWijs
- Keywords
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Adherence, Azathioprine, Knowledge, App, Phone, Education
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedicijnWijsOther
The mobile phone app MedicijnWijs will guide the participants with their azathioprine therapy during 6 weeks. Information about azathioprine is given as well as general information about IBD, specified to disease modality (Crohn's Disease and Ulcerative Colitis). Contact details of the patient's pharmacy are listed, questions about the patient's symptoms are asked, and push notifications are added to remind the patients to take their medication.
At the beginning of the 6-weeks guidance, two validated questionnaires that are translated and validated in Dutch will have to be filled in: the MARS-5 and the IBD-KID2. After 6 weeks, the participants have to fill out the same questionnaires again to assess potential changes in the scores compared to baseline. Also, a number of questions will be asked to assess the ease of use of MedicijnWijs.
| Study group | Role | What they receive |
|---|---|---|
| MedicijnWijs | Experimental | All participants will undergo the same intervention of using MedicijnWijs, and they will serve as their own control. Receives: Other: MedicijnWijs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to azathioprine therapy
Measured as the change in Medication Adherence Report Scale-5 (MARS-5) score compared to baseline. The MARS-5 score at the start and end of the study can range from 5 to 25 points. The higher the score, the better the adherence to azathioprine therapy. The difference in MARS-5 score compared to baseline will be assessed.
Measured: 6 weeks
Secondary outcomes (2)
Change in knowledge about IBD
Measured as the change in Inflammatory Bowel Disease-Knowledge Inventory Device 2 (IBD-KID2) score compared to baseline. The IBD-KID2 score at the start and end of the study can range from 0 to 15 points. The higher the score, the higher the knowledge about IBD. The difference in IBD-KID2 score compared to baseline will be assessed.
Measured: 6 weeks
Ease of use of MedicijnWijs assessed by a questionnaire
Assessed by separate questions
Measured: At the end of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start16 Mar 2022
- Primary completion16 Sep 2022 (estimated)
- Study completion16 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. L.J.J. (Luc) Derijks, Maxima Medical Center
- Investigators
- Luc JJ Derijks, PharmD, PhD, Principal investigator, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321485
- Sponsor's protocol ID
- 2022-MMC-029
- Acronym
- MEDICATION
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD
- ClinicalTrials.gov ID
- NCT05321485
- Acronym / sponsor ID
- MEDICATION / 2022-MMC-029
- Keywords
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Adherence, Azathioprine, Knowledge, App, Phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Sep 2022 (estimated)
- Study completion
- 16 Sep 2022 (estimated)
- First posted
- 11 Apr 2022 (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.
Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. It provides information about IBD and azathioprine. In this multicenter before-and-after study, the aim is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. This is done using two validated questionnaires that are translated to Dutch: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. These questionnaires are filled in at the beginning of the study period and after 6 weeks of using MedicijnWijs. This way a change in both scores can be assessed. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.
Detailed description
Rationale: medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. The aim of this study is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.
Objective: with this study, the effect of the mobile phone app MedicijnWijs on adherence to azathioprine therapy will be assessed. In addition, the effect on knowledge about IBD and the ease of use of MedicijnWijs will be studied as well.
Study design: this study is a multicenter before-and-after study. Study population: the study population are adolescents aged 12 up to and including 17 years old. All participants are diagnosed with IBD and are treated with azathioprine. This multicenter study will be conducted in Máxima Medical Center in Veldhoven, Catharina Hospital in Eindhoven, and Zuyderland Medical Center in Sittard-Geleen/Heerlen, The Netherlands.
Intervention: the participants will use the mobile phone app MedicijnWijs for 6 weeks. In this app, information about IBD and azathioprine is provided. Participants also receive questions about their symptoms through the app. Moreover, at the beginning of the study the participants have to fill in two validated questionnaires that are translated to Dutch in the app: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. After 6 weeks, the participants have to fill out the same questionnaires again to assess potential changes in the scores compared to baseline. Also, a number of questions will be asked to assess the ease of use of MedicijnWijs.
Main study parameters/endpoints: the main endpoint is change in adherence to azathioprine therapy measured as a change in MARS-5 score. In addition, the secondary endpoint change in knowledge about IBD measured as a change in IBD-KID2 score will be studied as well. The results of the secondary endpoint ease of use of MedicijnWijs will be presented descriptively.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: there are no risks associated with participation to this study as participants only have to use a mobile phone app and fill in two short questionnaires. MedicijnWijs has to be used for 6 weeks. The time burden per day varies from 0 to 10 minutes. The IBD treatment of the participants will not change, and participants will visit their doctors as frequently as usual. Only an additional introductory talk will be necessary, which will be scheduled during a regular outpatient clinic visit. No physical examinations, blood tests, or other tests will be done during this study apart from routine care of IBD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedicijnWijs | Experimental | Other: MedicijnWijsAll participants will undergo the same intervention of using MedicijnWijs, and they will serve as their own control. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 12 up to and including 17 years old
- Condition: IBD (Crohn's Disease and Ulcerative Colitis)
- Treatment: azathioprine
Key exclusion criteria (1 listed)
- Inability to use MedicijnWijs due to either low cognitive skills or the unavailability of a phone or other technical device to use the app on
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 |
|---|---|---|
| MedicijnWijsThe mobile phone app MedicijnWijs will guide the participants with their azathioprine therapy during 6 weeks. Information about azathioprine is given as well as general information about IBD, specified to disease modality (Crohn's Disease and Ulcerative Colitis). Contact details of the patient's pharmacy are listed, questions about the patient's symptoms are asked, and push notifications are added to remind the patients to take their medication. At the beginning of the 6-weeks guidance, two validated questionnaires that are translated and validated in Dutch will have to be filled in: the MARS-5 and the IBD-KID2. After 6 weeks, the participants have to fill out the same questionnaires again to assess potential changes in the scores compared to baseline. Also, a number of questions will be asked to assess the ease of use of MedicijnWijs. | Other | MedicijnWijs |
Primary outcome
Change in adherence to azathioprine therapy
Time frame: 6 weeks
Measured as the change in Medication Adherence Report Scale-5 (MARS-5) score compared to baseline. The MARS-5 score at the start and end of the study can range from 5 to 25 points. The higher the score, the better the adherence to azathioprine therapy. The difference in MARS-5 score compared to baseline will be assessed.
2 secondary outcomes
Change in knowledge about IBD
Time frame: 6 weeks
Ease of use of MedicijnWijs assessed by a questionnaire
Time frame: At the end of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- 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.
Luc JJ Derijks, PharmD, PhD contact
Luc JJ Derijks, PharmD, PhD principal investigator
Maxima Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedicijnWijs in people with Inflammatory Bowel Diseases and Crohn Disease, run by Maxima Medical Center at 3 sites 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaylee Stabel, BSc (+31629161384, kaylee.stabel@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adherence to azathioprine therapy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2022.