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
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
BMC Public Health 2010, 10:458 doi:10.1186/1471-2458-10-458Published: 5 August 2010
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.
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.
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.
This trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN126080005833347.