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Open Access Study protocol

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 Leiva1*, Marta Fajó2, Luís Escriche3, Francisco J Audera4, Sara López5, Ma Carmén Martín5, Rosa González5, Gaspar Tamborero6, Elena M García7, Rosa Duro8, Ramón Orueta9, Francisca Serra10, Pilar D'agosto P11, Jerónima Miralles1, Patricia Lorente1, Joan Llobera1, Ana Aurelia Iglesias12, Ruth Fernández13, María M Colom7, Aina M Buades1, Lucía Moreno14, Clara Vidal1 and The ADHERENCE group

Author Affiliations

1 Primary Care Research Unit of Mallorca, Baleares Health services-IbSalut, CAIBER, Mallorca, Spain

2 Faculty of Science, Microbiology and Public Health Department, Zaragoza University, Zaragoza, Spain

3 Son Ferriol Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

4 Monzón Health Centre, Aragon Health services-SaludAragón, Huesca, Spain

5 Actur Sur Health Centre, Aragon Health services-SaludAragón, Zaragoza, Spain

6 Coll D'en Rabassa Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

7 San Agustín Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

8 Santa María Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

9 Silleria Health Centre, Castilla la Mancha Health services-SESCAM, Toledo, Spain

10 Sineu Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

11 Son Serra Health Centre, Baleares Health services-IbSalut, Mallorca, Spain

12 Department of pharmacy, Baleares Health services-IbSalut, Mallorca

13 Biescas Health Centre, Aragon Health services-SaludAragón, Huesca, Spain

14 Sub-direction of nursing, Baleares Health services-IbSalut, Gabinete atención primaria, Mallorca, Spain

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BMC Cardiovascular Disorders 2010, 10:44  doi:10.1186/1471-2261-10-44

Published: 27 September 2010

Abstract

Background

Lowering 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/Design

The 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.

Measurement

The primary outcome is systolic blood pressure. The secondary outcomes are diastolic blood pressure, proportion of patients with adequately controlled blood pressure, and total cost.

Discussion

The 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 registration

Current controlled trials ISRCTN21229328