Behaviour change interventions to improve medication adherence in patients with cardiac disease: Protocol for a mixed methods study including a pilot randomised controlled trial

Abstract

BackgroundSuboptimal adherence to medication increases mortality and morbidity; individually tailored supportive interventions can improve patients’ adherence to their medication regimens. AimsThe study aims to use a pilot randomised controlled trial (RCT) to test the hypothesis that a theory-based, nurse-led, multi-faceted intervention comprising motivational interviewing techniques and text message reminders in addition to standard care will better promote medication adherence in cardiac patients compared to standard care alone. The pilot study will assess self-reported adherence or non-adherence to cardiovascular medication in patients referred to a cardiac rehabilitation program following hospital admission for an acute cardiac event and test the feasibility of the intervention. The study will examine the role of individual, behavioural and environmental factors in predicting medication non-adherence in patients with CVD. MethodsThis is a mixed- methods study including a nested pilot RCT. Twenty-eight cardiac patients will be recruited; an estimated sample of nine patients in each group will be required for the pilot RCT with 80% power to detect a moderate effect size at 5% significance, and assuming 50% loss to follow-up over the six month intervention. Participants will complete a paper-based survey (Phase one), followed by a brief semi-structured interview (Phase two) to identify their level of adherence to medication and determine factors predictive of non-adherence. Participants identified as ‘non-adherent’ will be eligible for the pilot randomised trial, where they will be randomly allocated to receive either the motivational interview plus text message reminders and standard care, or standard care alone. DiscussionNurse-led multi-faceted interventions have the potential to enhance adherence to cardiac medications. The results of this study may have relevance for cardiac patients in other settings, and for long-term medication users with other chronic diseases.