Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial

Alfonso Leiva,Gaspar Tamborero,Marta Fajó,Rosa Duro,Pilar D'Agosto P,Aina M Buades,Ramón Orueta,Luís Escriche,Francisco J Audera,Jerónima Miralles,Patricia Lorente,Joan Llobera,María M Colom,Ana Aurelia Iglesias,E García ,Rosa Chaves González ,M Carmen Martín ,Sara Morón López ,R García-Cañedo Fernández ,L Pablo Moreno ,Clara Vidal,Francisca Serra

doi:10.1186/1471-2261-10-44

Abstract

BackgroundLowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug.Methods/DesignThe proposed randomized controlled trial will include patients with a low adherence to medication and uncontrolled blood pressure. The intervention group will receive a multifactorial intervention during the first, third, and ninth months, to improve adherence. This intervention will include motivational interviews, pill reminders, family support, blood pressure self-recording, and simplification of the dosing regimen.MeasurementThe primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost.DiscussionThe trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice. Ethical approval was given by the Ethical Committee on Human Research of Balearic islands, Spain (approval number IB 969/08 PI).Trial registrationCurrent controlled trials ISRCTN21229328

Highlights

Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality
The trial will evaluate the impact of a multifactorial adherence intervention in routine clinical practice
The purpose of the present study is to evaluate the effectiveness of a multifactorial intervention that is designed to improve the systolic and diastolic blood pressure (BP) of patients who have low adherence to antihypertensive drug therapy (AHT) and elevated BP

Summary

Introduction

Lowering of blood pressure by antihypertensive drugs reduces the risks of cardiovascular events, stroke, and total mortality. Poor adherence to antihypertensive medications reduces their effectiveness and increases the risk of adverse events. In terms of relative risk reduction, an improvement in medication adherence could be as effective as the development of a new drug. Numerous antihypertensive agents can effectively lower BP and significantly adherence typically experience increased BP [11]. A report by the World Health Organization (WHO) addressed the general importance of improving adherence to long-term medical treatments [12]. It has been reported that low adherence can increase the cost of treating hypertension by 15-20%, and is associated with more frequent hospitalization, use of emergency services, and admission to intensive care [13]

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