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Clinical Trials/ISRCTN13762819
ISRCTN13762819
Completed
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 sites350 target enrollmentFebruary 25, 2013
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ConditionsCardiovascular risk for people with severe mental illnessesCirculatory SystemCardiovascular disease, unspecified

Overview

Phase
未知
Intervention
Not specified
Conditions
Cardiovascular risk for people with severe mental illnesses
Sponsor
Camden and Islington NHS Foundation Trust (UK)
Enrollment
350
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
February 25, 2013
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Camden and Islington NHS Foundation Trust (UK)

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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