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

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.