Managing cardiovascular risk for people with severe mental illnesses. A clinical trial in primary care. (PRIMROSE)

Not Applicable

Completed

• Conditions: Cardiovascular risk for people with severe mental illnesses; Circulatory System; Cardiovascular disease, unspecified

• Registration Number: ISRCTN13762819
• Lead Sponsor: Camden and Islington NHS Foundation Trust (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29396118 2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26868949

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-25
• Study Completion: 2017-08-31
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

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. Pre-existing CVD

Added 01/09/2015:
5. Currently pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 01/09/2015:<br>Total Cholesterol; Timepoint(s): Baseline, 6 and 12 months<br><br>Previous primary outcome measures from 30/05/2013 to 01/09/2015:<br>Total Cholesterol; Timepoint(s): Baseline, 3, 6 and 12 months<br><br>Original primary outcome measures:<br>CVD risk score; Timepoint(s): Baseline, 6 and 12 months