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Open Access 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

Hueiming Liu1, Anushka Patel1, Alex Brown2, Sandra Eades3, Noel Hayman4, Stephen Jan1, Ian Ring5, Greg Stewart6, Andrew Tonkin7, Tarun Weeramanthri8, Vicki Wade6, Anthony Rodgers1, Tim Usherwood9, Bruce Neal1, David Peiris1, Hugh Burke10, Christopher Reid7, Alan Cass1* and the Kanyini Vascular Collaboration and Kanyini GAP Study Team1

Author affiliations

1 The George Institute for International Health, PO Box M201, Missenden Road, NSW 2050, Australia

2 Baker IDI Centre for Indigenous Vascular & Diabetes Research PO Box 1294, Alice Springs, Northern Territory 0871, Australia

3 Baker IDI Heart and Diabetes Institute, PO Box 6492, St Kilda Road Central, Victoria 8008, Australia

4 Inala Indigenous Health Service, 64 Wirraway Pde, INALA, QLD, 4077, Australia

5 University of Wollongong, Northfields Ave, Wollongong NSW 2500, Australia

6 Sydney South West Area Health Service, Eastern Campus Of Liverpool Hospital Elizabeth St, Liverpool NSW 2170, Australia

7 Monash University, Victoria 3800 Australia

8 WA Health, Level 3, B Block, 189 Royal Street, East Perth WA 6004, Australia

9 The University of Sydney, PO Box 154, Westmead, NSW 2145. Australia

10 Maari Ma Aboriginal Corporation, 443 Argent Street, PO Box 339 Broken Hill, NSW, 2880, Australia

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Citation and License

BMC Public Health 2010, 10:458  doi:10.1186/1471-2458-10-458

Published: 5 August 2010

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.