Proceedings of the 2nd Brazilian Week of Inflammatory Bowel Disease

Aims: Evaluate the impact of an intervention program in non-adherent patients with ulcerative colitis (UC). Methods: Parallel randomized controlled clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registration ReBEC RBR-79dn4k. Non adherent patients according to the Morisky Green test (MGT) with UC were included. The program consisted of educational and behavioral interventions. Primary outcome: 180-day adherence rate according to MGT, with relative risk (RR) and 95%CI. Sample size of 90 participants was calculated for adherence, with 95% bilateral significance level and 80% probability of detection, exposed/unexposed ratio of 1, 50% positive unexposed and 80% positive exposed. Secondary outcome: quality of life (QoL) in 180 days according to SF-36. QoL analysis was performed by comparing the differences of medians of 8 SF-36 score domains, previous and post-interventions, using Student's t test. Variables that presented differences of p<0.20 were selected for regression. Analysis included data from August/2019 to May/2021. Results: Forty-six and 49 patients were allocated to the control (CG) and intervention (IG) groups, respectively, and 83 completed the research protocol. At baseline, 82 (86.3%) participants had moderate adherence, 56 (58.9%) being unintentional. Interventions remained effective as promoters of better QoL scores even after multivariate analysis, for the following domains: “Pain”, when adjusted for UC severity, gender, and marital status (β=18.352, p=0.004), “Vitality”, when adjusted for UC severity (β=10.568, p=0.015) and “Emotional Aspects”, when adjusted for disease severity, income, and education (β=24.907, p=0.041). There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (unintentional/both/intentional) as confounder, or when considering the best scenario, if all lost to follow-up from the IG were adherent. Discussion/Conclusions: The patients included were non-adherent at baseline, which is a favorable point of this study, and to our knowledge there is no other clinical trial with this inclusion criteria for UC patients. The contribution of the results to the national survey is also noteworthy, since no records of trials with a similar objective to the present research were found in the ReBEC for IBD. Exposure to the proposed intervention program was not able to produce a significant difference between comparative groups in the rate of medication adherence, however, there was a significant improvement in QoL. This result is extremely important for patients with UC, as it is a chronic disease with a recognized negative impact on QoL.