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BMC Public Health
Published in: BMC Public Health 1/2010

Open Access 01-12-2010 | Study protocol

Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk

Authors: Hueiming Liu, Anushka Patel, Alex Brown, Sandra Eades, Noel Hayman, Stephen Jan, Ian Ring, Greg Stewart, Andrew Tonkin, Tarun Weeramanthri, Vicki Wade, Anthony Rodgers, Tim Usherwood, Bruce Neal, David Peiris, Hugh Burke, Christopher Reid, Alan Cass, the Kanyini Vascular Collaboration and Kanyini GAP Study Team

Published in: BMC Public Health | Issue 1/2010

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Abstract

Background

The Kanyini Guidelines Adherence with the Polypill (Kanyini-GAP) Study aims to examine whether a polypill-based strategy (using a single capsule containing aspirin, a statin and two blood pressure-lowering agents) amongst Indigenous and non-Indigenous people at high risk of experiencing a cardiovascular event will improve adherence to guideline-indicated therapies, and lower blood pressure and cholesterol levels.

Methods/Design

The study is an open, randomised, controlled, multi-centre trial involving 1000 participants at high risk of cardiovascular events recruited from mainstream general practices and Aboriginal Medical Services, followed for an average of 18 months. The participants will be randomised to one of two versions of the polypill, the version chosen by the treating health professional according to clinical features of the patient, or to usual care. The primary study outcomes will be changes, from baseline measures, in serum cholesterol and systolic blood pressure and self-reported current use of aspirin, a statin and at least two blood pressure lowering agents. Secondary study outcomes include cardiovascular events, renal outcomes, self-reported barriers to indicated therapy, prescription of indicated therapy, occurrence of serious adverse events and changes in quality-of-life. The trial will be supplemented by formal economic and process evaluations.

Discussion

The Kanyini-GAP trial will provide new evidence as to whether or not a polypill-based strategy improves adherence to effective cardiovascular medications amongst individuals in whom these treatments are indicated.

Trial Registration

This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.
Appendix
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Metadata
Title
Rationale and design of the Kanyini guidelines adherence with the polypill (Kanyini-GAP) study: a randomised controlled trial of a polypill-based strategy amongst Indigenous and non Indigenous people at high cardiovascular risk
Authors
Hueiming Liu
Anushka Patel
Alex Brown
Sandra Eades
Noel Hayman
Stephen Jan
Ian Ring
Greg Stewart
Andrew Tonkin
Tarun Weeramanthri
Vicki Wade
Anthony Rodgers
Tim Usherwood
Bruce Neal
David Peiris
Hugh Burke
Christopher Reid
Alan Cass
the Kanyini Vascular Collaboration and Kanyini GAP Study Team
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2010
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-10-458

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