The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD

NCT05321485 | Unknown

• 1 other identifier: 2022-MMC-029
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Adherence; Azathioprine; Knowledge; App; Phone; Education

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Change in knowledge about IBD

  6 weeks

• Ease of use of MedicijnWijs assessed by a questionnaire

  At the end of 6 weeks

Study Arms (1)

MedicijnWijs

EXPERIMENTAL

All participants will undergo the same intervention of using MedicijnWijs, and they will serve as their own control.

Other: MedicijnWijs

Interventions

MedicijnWijs OTHER

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.

MedicijnWijs

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 12 up to and including 17 years old
• Condition: IBD (Crohn's Disease and Ulcerative Colitis)
• Treatment: azathioprine

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (3)

Catharina Hospital

Eindhoven, North Brabant, 5623EJ, Netherlands

NOT YET RECRUITING

Zuyderland Medisch Centrum

Heerlen, North Brabant, 6419PC, Netherlands

NOT YET RECRUITING

Maxima Medical Center

Veldhoven, North Brabant, 5500VB, Netherlands

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Alzheimer Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Luc JJ Derijks, PharmD, PhD

  Maxima Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaylee Stabel, BSc

CONTACT

+31629161384; kaylee.stabel@mmc.nl

Luc JJ Derijks, PharmD, PhD

CONTACT

l.derijks@mmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: L.J.J. (Luc) Derijks, PharmD, PhD, hospital pharmacist-clinical pharmacologist

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: March 16, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)