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

Background: Suboptimal adherence to medication increases mortality and morbidity; individually tailored supportive interventions can improve patients' adherence to their medication regimens. Aims: The study aims to use a pilot randomised controlled trial (RCT) to test the hypothesis that a theorybased, 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. Methods: This 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 semistructured 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. Discussion: Nurse-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 longterm medication users with other chronic diseases.

Medication adherence and predictive factors in patients with cardiovascular disease: A cross‐sectional study

“…Participants were patients with cardiac disease who were admitted to a hospital in Sydney for an acute cardiac event such as myocardial infarction or percutaneous coronary intervention, or who had been referred to and attended a cardiac rehabilitation program (Al-Ganmi et al, 2018). The acute cardiac patient population of the hospital comprised approximately 125 patients with CVD admitted per month to the cardiac ward, with 18% uptake of referrals to the cardiac rehabilitation centre (unpublished hospital data).…”

“…The validity and reliability of the study instruments to detect medication non-adherent behaviors in patients with CVD in various cardiac settings have been established (Al-Ganmi et al, 2018). The Medication Adherence Questionnaire (MAQ) (Morisky et al, 1986) is a fouritem scale used to assess medication adherence and adherence determinants such as forgetfulness, carelessness, efficacy and adverse effects.…”

Levels of adherence to treatment, illness perception and acceptance of illness in patients with coronary artery disease - descriptive and correlational study

“…Despite the established efficacy of these medications in clinical trials for preventing and managing cardiovascular diseases (CVDs), their practical impact in real-world settings is somewhat diminished, attributed in part to suboptimal medication adherence. Research findings suggest medication non-adherence rates in heart diseases ranging from 33% to over 55% [ 9 , 10 ]. Notably, a comprehensive meta-analysis involving nearly 2 million patients revealed that only 60% adhered to their cardiovascular medications.…”