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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial

Authors: David Osborn, Alexandra Burton, Kate Walters, Irwin Nazareth, Samira Heinkel, Lou Atkins, Ruth Blackburn, Richard Holt, Racheal Hunter, Michael King, Louise Marston, Susan Michie, Richard Morris, Steve Morris, Rumana Omar, Robert Peveler, Vanessa Pinfold, Ella Zomer, Thomas Barnes, Tom Craig, Hazel Gilbert, Ben Grey, Claire Johnston, Judy Leibowitz, Irene Petersen, Fiona Stevenson, Sheila Hardy, Vanessa Robinson

Published in: Trials | Issue 1/2016

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Abstract

Background

People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices.

Methods/Design

The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care.

Discussion

The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices.

Trial registration

Current Controlled Trials ISRCTN13762819. Date of Registration: 25 February 2013.
Date and Version Number: 27 August 2014 Version 5.
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Metadata
Title
Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial
Authors
David Osborn
Alexandra Burton
Kate Walters
Irwin Nazareth
Samira Heinkel
Lou Atkins
Ruth Blackburn
Richard Holt
Racheal Hunter
Michael King
Louise Marston
Susan Michie
Richard Morris
Steve Morris
Rumana Omar
Robert Peveler
Vanessa Pinfold
Ella Zomer
Thomas Barnes
Tom Craig
Hazel Gilbert
Ben Grey
Claire Johnston
Judy Leibowitz
Irene Petersen
Fiona Stevenson
Sheila Hardy
Vanessa Robinson
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1176-9

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