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

被引：15

作者：

Osborn, David ^{[1
]}

Burton, Alexandra ^{[1
]}

Walters, Kate ^{[2
]}

Nazareth, Irwin ^{[2
]}

Heinkel, Samira ^{[1
]}

Atkins, Lou ^{[3
]}

Blackburn, Ruth ^{[1
]}

Holt, Richard

Hunter, Racheal ^{[2
]}

King, Michael ^{[1
]}

Marston, Louise ^{[2
]}

Michie, Susan ^{[4
]}

Morris, Richard ^{[5
]}

Morris, Steve ^{[6
]}

Omar, Rumana ^{[2
]}

Peveler, Robert ^{[4
]}

Pinfold, Vanessa ^{[7
]}

Zomer, Ella ^{[2
]}

Barnes, Thomas

Craig, Tom ^{[8
]}

Gilbert, Hazel ^{[2
]}

Grey, Ben

Johnston, Claire ^{[9
]}

Leibowitz, Judy ^{[9
]}

Petersen, Irene ^{[2
]}

Stevenson, Fiona ^{[2
]}

Hardy, Sheila ^{[10
]}

Robinson, Vanessa ^{[11
]}

机构：

[1] UCL, Fac Brain Sci, Div Psychiat, Epidemiol & Appl Clin Res Dept, 6th Floor,Maple House,149 Tottenham Court Rd, London W1T 7NF, England

[2] UCL, Inst Epidemiol & Hlth Care, Dept Primary Care & Populat Hlth, Rowland Hill St, London NW3 2PF, England

[3] UCL, Ctr Behav Change, Dept Clin Educ & Hlth Psychol, Div Psychol & Language Sci,Fac Brain Sci, 1-19 Torrington Pl, London WC1E 7HB, England

[4] Univ Southampton, Fac Med, Human Dev & Hlth Acad Unit, Southampton SO17 1BJ, Hants, England

[5] UCL, Inst Epidemiol & Hlth Care, UCL Dept Appl Hlth Res, 1-19 Torrington Pl, London WC1E 7HB, England

[6] Univ Bristol, Sch Social & Community Med, Canynge Hall,39 Whatley Rd, Bristol BS8 2PS, Avon, England

[7] McPin Fdn, 32-36 Loman St, London SE1 0EH, England

[8] Univ London Imperial Coll Sci Technol & Med, Fac Med, Dept Med, Commonwealth Bldg,Hammersmith Campus,Cane Rd, London W12 0NN, England

[9] Camden & Islington NHS Fdn Trust, 4th Floor,E Wing,Eas,St Pancras Hosp,4 St Pancras, London NW1 0PE, England

[10] Univ Northampton, Berrywood Hosp, Berrywood Dr, Northampton NN5 6UD, England

[11] Rethink Mental Illness, 89 Albert Embankment, London SE1 7TP, England

来源：

TRIALS | 2016年 / 17卷

关键词：

Primary care; Severe mental illnesses; Cardiovascular risk; CORONARY-HEART-DISEASE; PHYSICAL-ACTIVITY; METABOLIC SYNDROME; PRACTICE NURSES; SCHIZOPHRENIA; MORTALITY; UK; ANTIPSYCHOTICS; VALIDATION; MANAGEMENT;

D O I：

10.1186/s13063-016-1176-9

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：12

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