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21 March 2013
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| [ Print-friendly version ] |
| Managing cardiovascular risk for people with severe mental illnesses. A clinical trial in primary care. (PRIMROSE) |
| ISRCTN | ISRCTN13762819 |
| DOI | 10.1186/ISRCTN13762819 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Managing cardiovascular risk for people with severe mental illnesses. A clinical trial in primary care. (PRIMROSE) |
| Scientific title | Prediction and management of cardiovascular risk for people with severe mental illnesses. A cluster randomised controlled trial in primary care (PRIMROSE) |
| Acronym | PRIMROSE2 |
| Serial number at source | 14015 |
| Study hypothesis |
The objective of the study is to test the effectiveness and cost effectiveness of a primary care led intervention to reduce cardiovascular risk in patients with severe mental illnesses.
The specific objectives are: 1. to establish the effectiveness of the intervention in reducing total cholesterol and overall cardiovascular risk scores over a 12 month period compared with standard care 2. to determine the impact of the intervention on the following CVD risk factors: fasting glucose, blood pressure, BMI, waist circumference, HDL cholesterol, 3 month smoking abstinence 3. to determine whether the intervention improves uptake of statins, adherence to statins and attendance at appointments 4. to establish the cost-effectiveness of the intervention considering the costs of the intervention itself and other direct health care costs alongside the outcomes, 5. to determine the effectiveness of the intervention on the number of hospital admissions, patient satisfaction with services, quality of life and mental health outcomes More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14015 |
| Lay summary |
Background and study aims
People with severe mental illnesses (SMI) die early from cardiovascular disease (CVD). They have increased CVD risk factors including abnormal lipids, diabetes, smoking and obesity. They make frequent contact with primary care, yet are less likely to be screened for risk factors or receive interventions such as statins. In this study, we aim to test the effectiveness of an intervention with GP practices working to reduce CVD risk in people with SMI. The intervention will include physical health reviews, prescription of medications such as statins and monitoring of adherence to recommended treatments. Who can participate? The study aims to recruit 400 patients with severe mental illnesses (Schizophrenia, Persistent Delusional Disorder, Schizoaffective Disorder or Bipolar Affective Disorder), aged 30 years or older with raised total cholesterol or a 10 year CVD risk score above 10% from 40 GP practices across England. What does the study involve? All participants with SMI registered with GP practices in the trial will be screened for CVD risk. 40 general practices will be involved, 20 using the new intervention and 20 providing standard care. Over a period of one year, approximately 10 participants from each practice with a raised total cholesterol or CVD 10 year risk score above 10% will either receive the intervention or treatment as usual. The intervention will involve intensive management of CVD risk factors with monthly appointments to monitor progress with reducing cholesterol, prescription and adherence to statins and signposting to services for weight management and smoking cessation where other CVD risk factors are detected. At the end of the study, we will establish whether practices trained in the intervention reduce CVD risk more than standard care. What are the possible benefits and risks of participating? Those in the intervention will receive help in reducing the risk of developing cardiovascular disease. The study will provide evidence on how to reduce cardiovascular disease risk for people with severe mental illness across the NHS. The main risk will be around the prescription of statins to people with severe mental illnesses. There is little research on the effectiveness of statins in people with severe mental illnesses, however statins have been found to be effective and safe in the general population. Any reported side effects will be closely monitored at monthly follow ups with the GP/practice nurse. Where is the study run from? The study is run by University College London in collaboration with Camden and Islington NHS Foundation Trust. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start in May 2013. Participants will be enrolled on the study for a maximum period of two years. Who is funding the study? National Institute for Health Research (NIHR). Who is the main contact? Miss Alexandra Burton a.burton@ucl.ac.uk |
| Ethics approval | NRES Committee London - City Road & Hampstead, 10th January 2013, ref: 12/LO/1934 |
| Study design | Cluster randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiovascular risk for people with severe mental illnesses |
| Participants - inclusion criteria |
1. GP patients with a computer diagnosis of severe mental illness (SMI), i.e. Schizophrenia (ICD-10, F20), Persistent Delusional disorder (ICD-10, F22), Schizoaffective disorder (ICD-10, F25), Bipolar affective disorder (ICD-10, F31)
2. Raised total cholesterol over 5mmol/l or CVD 10 year risk score above 10% 3. Male & Female; Upper Age Limit 85 years ; Lower Age Limit 30 years 4. Able to give written informed consent |
| Participants - exclusion criteria |
1. Too acutely unwell defined as under acute psychiatric care
2. Primary diagnosis of an organic mental health problem and/or severe cognitive impairment 3. Life expectancy < 6 months 4. Preexisting CVD |
| Anticipated start date | 01/05/2013 |
| Anticipated end date | 02/11/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | Planned Sample Size: 398; UK Sample Size: 398 |
| Interventions |
Standard care
Primrose intervention, Practice led intensive CVD risk management service including: 1. Brief behavioural advice and support on diet, exercise and smoking 2. Referral to support services such as smoking cessation and weight management programmes 3. Prescription of statins and other pharmacological interventions such as nicotine replacement therapy 4. Monitoring of adherence to treatments and attendance at appointments and monitoring of progress made with goals and CVD risk targets Follow Up Length: 12 month(s) |
| Primary outcome measure(s) | CVD risk score; Timepoint(s): Baseline, 6 and 12 months |
| Secondary outcome measure(s) | Cholesterol; Timepoint(s): Baseline, 6 and 12 months |
| Sources of funding | NIHR (UK) - Central Commissioning Facility |
| Trial website | |
| Publications | |
| Contact name | Ms Alexandra Burton |
| Address |
Charles Bell House
67-73 Riding House Street |
| City/town | London |
| Zip/Postcode | W1W 7EJ |
| Country | United Kingdom |
| a.burton@ucl.ac.uk | |
| Sponsor | Camden and Islington NHS Foundation Trust (UK) |
| Address |
Bedford House
3rd Floor 125-133 Camden High Street |
| City/town | London |
| Zip/Postcode | NW1 0PE |
| Country | United Kingdom |
| Sponsor website: | http://www.noclor.nhs.uk/ |
| Date applied | 21/02/2013 |
| Last edited | 27/02/2013 |
| Date ISRCTN assigned | 25/02/2013 |
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