N010 A cluster randomised controlled trial testing the effect of a theoretical and evidence-based tailored multimedia intervention to improve medication adherence in inflammatory bowel disease patients
A. Linn*1, L. van Dijk2, J. van Weert1, B. Gebeyehu1, A. van Bodegraven3, E. Smit1
1University of Amsterdam / Amsterdam School of Communication Research (ASCoR), Communication Science, Amsterdam, Netherlands, 2Netherlands institute for health services research, Department Pharmaceutical care, Utrecht, Netherlands, 3ATRIUM-ORBIS Medical Centre, Department of Internal Medicine, Gastroenterology and Geriatrics, Sittard, Netherlands
Non-adherence rates within the inflammatory bowel disease (IBD) population have been reported over 40%. Poor medication adherence can, amongst other factors, leads to an increase in health care costs, probability of relapse, and a reduced quality of life. As a consequence, many adherence (unsuccessful) interventions have been developed. These interventions are often aimed at all patients, regardless of the barriers patients perceive. In a theoretical and evidence-based Tailored Multimedia Intervention (TMI), new communication technologies were used as an add-on to usual consultations, with the expectation of synergistic effects. The objective of this study is to test the effectiveness of TMI on patient adherence, satisfaction, and adherence barriers.
A cluster randomised controlled trial was conducted in 6 hospitals, 8 nurses, and 160 IBD patients initiating immunosuppressive or biological therapy (ie, azathioprine, mercaptopurine, tioguanine, methotrexate, infliximab, or adalimumab) for the first time. Power analysis with adherence as primary outcome revealed that, with alpha set at 0.05 and power at 0.40 (medium effect size), a minimum of 176 patients was required. Patient satisfaction with communication about the disease and treatment; support with medication use; affective communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after 6 months. The effectiveness of the intervention was assessed by using ANOVAs.
No intervention effect on adherence and beliefs were shown at 3 weeks (F [1, 94] = 0.324, p = 0.570 resp. F [1, 94] = 0.874, p = 0.044), and at 6 months (F [1, 63] = 0.354, p = 0.554 resp. F [1, 62] = 0.159, p = 0.691). After 3 weeks positive intervention effects were found for patient satisfaction with nurses’ affective communication (F [1, 95] = 5.66, p = 0.019), and self-efficacy (F [1, 89] = 4.18, p = 0.044); for the latter also at 6 months (F [1, 62] = 3.76, p = 0.057).
Adherence rates were better in the experimental group than in the control group at both time points, this difference was not significant. There might not have been sufficient power to detect changes in adherence nor sufficient room for improvement in adherence. Adherence and beliefs were high in both groups, which might indicate a ceiling effect. By combining interpersonal and technology-mediated components, this intervention resulted in positive changes in the application of 1 of the most essential communication skills, being affective communication, and it reduced practical barriers to medication adherence.