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A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting

Hill, Kate PhD; Walwyn, Rebecca PhD; Camidge, Diana MSc; Murray, Jenni PhD; Meads, David MSc; Reynolds, Greg FRCP; Farrin, Amanda MSc; House, Allan DM

The Journal of Cardiovascular Nursing: November/December 2016 - Volume 31 - Issue 6 - p 507–516
doi: 10.1097/JCN.0000000000000294
ARTICLES: Prevention

Background: A healthy diet, taking exercise, and not smoking or consuming alcohol in excess are important to reduce the risk of cardiovascular disease either alone or in combination with statin medication. Health education, including providing information to patients on healthy living and guidance on how to achieve it, is a key nursing function.

Objectives: This study aims first to assess the feasibility of conducting a full-scale trial of lifestyle referral assessment as shown by recruitment rate, data collection, and follow-up and second to assess proof of concept and explore possible mechanisms of change.

Methods: This was a single-center, randomized, 2-arm, parallel-group, unblinded feasibility trial conducted in an acute teaching hospital trust. Participants were followed up at 3 and 6 months after randomization.

Results: Eight hundred eighty-seven patients were screened for eligibility, of whom 132 (15%) were randomized into the trial. Of the patients allocated to the individualized assessment, 27% accepted referral or self-referred by 3 months in comparison to 5% allocated to the usual assessment.

Conclusions: We demonstrated that a full-scale trial is feasible and that an individualized approach increased the number of patients accepting referral to a formal program and initiating lifestyle change. However, we should consider the aim of the assessment and ways in which the process of change can be optimized in order to produce long-term benefit for patients.

Trial registration: current controlled trials ISRCTN41781196.

Kate Hill, PhD Senior Research Fellow, Leeds Institute of Health Sciences, University of Leeds, United Kingdom.

Rebecca Walwyn, PhD Principal Statistician, Clinical Trials Research Unit, University of Leeds, United Kingdom.

Diana Camidge, MSc Research Officer, Leeds Institute of Health Sciences, University of Leeds, United Kingdom.

Jenni Murray, PhD Senior Research Fellow, Leeds Institute of Health Sciences, University of Leeds, United Kingdom.

David Meads, MSc Associate Professor, Leeds Institute of Health Sciences, University of Leeds, United Kingdom.

Greg Reynolds, FRCP Consultant Cardiologist, Leeds Teaching Hospitals Trust, Leeds, United Kingdom.

Amanda Farrin, MSc Chair, Clinical Trials Research Unit, University of Leeds, United Kingdom.

Allan House, DM Professor of Liaison Psychiatry, Leeds Institute of Health Sciences, University of Leeds, United Kingdom.

The CLAHRC LYB vascular theme collaborators: Prof Bob Lewin, Prof Simon Gilbody, and Prof Ian Watt at the University of York and Dr Lucy Jackson at NHS Leeds, and the CLAHRC Improve project team. Data collection was assisted by Sian Davies, a student at Leeds University Medical School, during a summer research placement.

This work was supported by a National Institute for Health Research (NIHR) grant (reference KRD/012/001/006).

This article presents independent research by the NIHR Collaboration for Leadership in Applied Health Research and Care for Leeds, York, and Bradford (CLAHRC LYB), a pilot that ended in 2013. Further details about the new NIHR CLAHRC Yorkshire and Humber can be found at www.clahrc-yh.nihr.ac.uk. The views and opinions expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health.

The authors have disclosed that they have no significant relationship with, or financial interest in, any commercial companies pertaining to this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s Web site (www.jcnjournal.com).

Correspondence Kate Hill, PhD, Academic Unit of Psychiatry Behavioural Sciences Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah Bldg, 101 Clarendon Rd, Leeds, United Kingdom LS2 9LJ (k.m.hill@leeds.ac.uk).

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