DOP044. Patient education in a 14 month randomized trial fails to improve adherence in ulcerative colitis: Influence of demographic and clinical parameters on non-adherence
S. Nikolaus1, S. Schreiber1, B. Siegmund2, B. Bokemeyer3,4, E. Bästlein5, O. Bachmann6, W. Kruis7, German IBD Study Group8, 1University Hospital Schleswig-Holstein, Campus Kiel, 1st Med. Department, Kiel, Germany, 2Charité Universitätsmedizin Berlin, Gastroenterology, Infectious Diseases and Rheumatology, Berlin, Germany, 3Gastroenterology Practice, Minden, Minden, Germany, 4Gastroenterology Practice, Minden, Germany, 5Magen Darm Zentrum Köln, MDZ Köln, Köln, Germany, 6Medizinische Hochschule Hannover, Gastroenterology, Hannover, Germany, 7Evangelisches Krankenhaus Kalk, Gastroenterology, Köln, Germany, 8Charité Universitätsmedizin Berlin, Gastroenterology, Berlin, Germany
Recent observatory studies suggest that non-adherence to 5-ASA therapy during remission is a main factor for relapse in ulcerative colitis (UC) (1). Patient education may improve adherence. We investigated demographic and clinical parameters associated with non-adherence and influence of patient education on 5-ASA adherence in a randomized, prospective clinical trial.
247 patients with inactive or mildly active UC (CAI < 9) were randomized to standard care alone (n = 122) or an additional standardized patient education programme within 4 weeks after inclusion (n = 125). All patients had to receive 5-ASA (1.2–4.8 g/d). Six visits were scheduled during the 14 months trial period. At each visit urine samples were collected to assess 5-ASA exposure (non adherence= absence of 5-ASA). Primary endpoint was adherence at all visits. Secondary endpoints were quality of life (IBDQ), disease activity, partial adherence, white-coat compliance and self-assessment of adherence.
Patients were well balanced (disease activity, disease localization, concomitant therapy, clinical and socio-demographic characteristics). Baseline non-adherence was high (52.4%) without difference between the groups. The primary endpoint was not met with non-adherence in 52.4% of patients in the education group vs. 52.5% in the standard care group (P = 0.99). Overall, between 17.1–24.6% of patients had mild to moderate disease (CAI 4–9) and <5% had an acute relapse without difference in adherence at any time point between the groups. No difference was seen between the standard care- and intervention group with regard to all secondary endpoints.
Most interestingly, particularly patients with young age were non-adherent (18–40 yrs: 70%; 63/90 vs. 40–60 yrs: 47%; 54/115 and >60 yrs: 30.2%; 13/43). High levels of non-adherence were associated with short duration of disease (2–5 yrs: 55.9%; 57/102 vs. 5–10 yrs: 52.2%; 35/67, 10–15 yrs: 51.2%; 21/41 and >15 yrs: 44.7%; 17/38). A trend for a relationship between non-adherence and low education levels was seen (low education (only basic school): 63.8%, 30/47 vs. higher education levels (trade school): 41.8%, 28/67 and “Abitur”/university: 58%, 65/112).
Although >25% of the population were not in remission throughout the study no relationship between disease activity and adherence was seen. Non adherence was associated with younger age, short duration of disease and lower education levels. While a structured intervention using a patient education program failed to improve adherence in this particular group, efforts should be maximized to motivate this high-risk population for adherence.
1. Khan et al., Aliment Pharmacol Therap 2012