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