Kate Hill1, Rebecca Walwyn, Diana Camidge, Jenni Murray, David Meads, Greg Reynolds, Amanda Farrin, Allan House. 1. 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.
Abstract
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.
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.
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