Improving adherence in ulcerative colitis (UC) patients on 5-ASA.

5-ASA plays an important role in UC treatment guidelines and is recommended as
induction of remission therapy for left sided colitis and mild-moderate
extensive colitis. Medication adherence occurs when the patient carries out a
therapy in the way in which it was intended by the treating physician. The
reported prevalence of medication non-adherence varies from 40-91% in UC
patients on 5-ASA and is comparable with those seen in other chronic illnesses.
A high percentage of non-adherent patients who are at an increased risk for
relapse is likely to contribute to higher costs associated with the treatment
of UC. Our hypothesis is that once daily dosing and the use of interactive apps
improves adherence in UC patients on 5-ASA.

The aim of our study is to assess
1) The influence of once daily versus twice daily use of 5-ASA medication on
adherence
2) The influence of the use of apps on adherence in ulcerative colitis
patients on 5-ASA

This study is a randomized, controlled prospective multi-centre trial
including 220 patients with ulcerative colitis. Patients will be randomly
assigned to either once daily Mezavant® (2400 mg) or twice daily Mezavant®
(2dd1200 mg), with a total follow up period of 18 months. Primary outcome is
adherence, measured by presence of 5-ASA metabolites in urine at six months.
Secondary outcomes are compliance measured by presence of 5-ASA metabolites in
urine at 12 and 18 months. quality of life, clinical and endoscopic remission,
costs and safety. Patients are randomised to either once daily 2400 mg Mezavant
or twice daily 1200 mg Mezavant, and to either the standard treatment regime
or assisted treatment regime with interactive apps on their mobile phone
and/or ipad, with a total study follow up of 18 months. A sigmoidoscopy is
performed at baseline, at the end of the study, or at withdrawal. Patients will
be asked to visit the outpatient clinic or contact the IBD nurse via the app
every 3-6 months, to collect urine and faeces samples, and to complete
questionnaires regarding adherence (adherence questionnaire), clinical
response, adverse events and health-related quality of life. Every six months
blood samples are collected.

Randomisation:
Once versus twice daily 5-ASA therapy to improve their compliance to 5ASA//Text
messages and alerts via a specific app on their mobile phone versus standard
of care to improve their compliance to 5ASA

The risk of participation in the current study is considered to be low compared
to standard 5-ASA treatment outside this study protocol, since treatment in the
study does not gradually differ from current practice. Patients in the
intervention group may have a higher chance of reaching and maintaining
clinical and endoscopic remission if suboptimal adherence can be increased by
either once daily dosage or by assisted treatment regime with the use of apps.
Patients have to bring some 3 additional visits to the hospital, or fill in an
app. At entrance, and at the end of the study a sigmoidoscopy is performed.
Every three months urine and faecal analysis have to be performed, at least
every six months laboratory analysis. Next to this, patients will be asked to
complete questionnaires on adherence, clinical remission and quality of life 6
times during treatment.