ISRCTN13762819已完成未知
Prediction and management of cardiovascular risk for people with severe mental illnesses. A cluster randomised controlled trial in primary care (PRIMROSE)
Camden and Islington NHS Foundation Trust (UK)0 个研究点目标入组 350 人开始时间: 2013年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 350
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29396118 2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26868949
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 01/09/2015:
- •1. GP patients with a computer diagnosis of severe mental illness (SMI), i.e. Schizophrenia, Persistent Delusional disorder, Schizoaffective disorder, Bipolar affective disorder
- •2. Raised total cholesterol of 5 mmol/l or more or total cholesterol/HDL ratio of 4 mmol/l or more AND one or more of the following risk factors:
- •2.1. BMI > 30 kg/m2
- •2.2. Current smoker
- •2.3. Blood pressure >140mm Hg systolic AND/OR >90 mm Hg diastolic on two or more consecutive occasions
- •2.4. HbA1c of 42- 47 mmol/mol (6.0-6.4%)
- •2.5 Diagnosis of hypertension
- •2.6 Diagnosis of diabetes
- •3. Male & Female; Upper Age Limit 75 years ; Lower Age Limit 30 years
- •4. Able to give written informed consent
- •Previous inclusion criteria from 30/05/2013 to 01/09/2015:
- •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 5 mmol/l or total cholesterol/HDL ratio above 4 mmol/lAND one or more of the following risk factors:
- •2.1. BMI > 30 kg/m2
- •2.2. Current smoker
- •2.3. Blood pressure >140mm Hg systolic AND/OR >90 mm Hg diastolic on two or more consecutive occasions
- •2.4. HbA1c of 42- 47 mmol/mol (6.0-6.4%)
- •3. Male & Female; Upper Age Limit 75 years ; Lower Age Limit 30 years
- •4. Able to give written informed consent
- •Original 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
排除标准
- •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. Pre-existing CVD
- •Added 01/09/2015:
- •5. Currently pregnant
研究者
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