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Impact of a tailored patient preference intervention in adherence to 5-aminosalicylic acid medication in ulcerative colitis: Results from an exploratory randomized controlled trial

Moshkovska, Tetyana MD1*; Stone, Margaret A. PhD2; Smith, Roger M. PhD3; Bankart, John PhD2; Baker, Richard MD2; Mayberry, John F. DSc1

doi: 10.1002/ibd.21570
Original Clinical Articles

Background: Up to 40% of patients with ulcerative colitis (UC) fail to comply with 5-aminosalicylic acid (5-ASA) therapy. This study aimed to evaluate multifaceted adherence-enhancing interventions for oral 5-ASA therapy in UC and consider changes in health beliefs and satisfaction with information.

Methods: Adults attending a UK gastroenterology outpatient clinic were recruited to an exploratory randomized controlled trial. The tailored intervention included educational and motivational components, plus options including simplified dosing regimes and practical reminders such as pill dispensers. Adherence was assessed objectively at baseline and after 1 year based on levels of urinary 5-ASA and N-acetly-5-ASA concentration. Changes in relevant beliefs and satisfaction with information were measured using validated questionnaires.

Results: Seventy-one people completed the study. Adherence levels in the study population were relatively high at baseline (76%) but a decline in adherence levels over the study period was noted. However, at follow-up adherence in the intervention group was 44% greater than in the control group. Intervention group status had a significant positive impact on maintaining adherence levels after adjusting for potential confounders including baseline adherence (P = 0.001). This finding was supported by the results of a sensitivity analysis including patients who withdrew from the study. Changes in questionnaire scores suggested a positive effect of the intervention on satisfaction with information (P < 0.001).

Conclusions: The multifaceted approach studied has potential for implementation in routine care for enhancing persistence with 5-ASA and thus improving patient outcomes. (Inflamm Bowel Dis 2011;)

1 Digestive Disease Centre, University Hospitals of Leicester NHS Trust, UK

2 Department of Health Sciences, University of Leicester, UK

3 Department of Chemistry Loughborough University, UK

*Reprints: Digestive Disease Centre, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW, UK


Received 24 September 2010; Accepted 11 October 2010

Published online 6 January 2011 in Wiley Online Library (

Supported by funding from University Hospitals of Leicester NHS Trust. A grant for this project was made to the charity GEAR (Gastrointestinal Education and Research) by Ferring Pharmaceuticals Ltd.

© Crohn's & Colitis Foundation of America, Inc.
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