NCT01182012

Reduction of Cardiovascular Risk in Severe Mental Illness

Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 391 (estimated)
• Sponsor: Consorci Hospitalari de Vic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Patients with severe mental illness (SMI) have a higher prevalence of cardiovascular risk factors (CVRF) than the general population and a control of these risk factors poorer. Serious mental illness often causes health teams to focus interventions in mental illness and put aside the CVRF. Objectives: This project aims to assess the CVRF, stratify the cardiovascular risk, adequate drug treatment to reduce this risk and evaluate the effectiveness of an intervention by professional community nurses in patients with SMI. Materials and Methods: Prospective study of a cohort of patients over 18 years with a diagnosis of SMI with two cross sections to evaluate the cardiovascular risk and adequacy of drug treatment. The investigators calculate the risk to the cardiovascular risk tables with the SCORE (Systematic Coronary Risk Evaluation) for countries of low cardiovascular risk and the of Framingham REGICOR (Heart registry of Girona, Spain). The adequacy of pharmacotherapy will be assessed contrasting it with the recommendations of the Program of Preventive Activities and Health Promotion of Family medical association. The intervention will be conducted by professional nurses and consist of an initial psycho-educational intervention, and two more reinforcement throughout twelve months, of duration less than 30 minutes that will be addressed in an integrated manner the clinical situation with regard to cardiovascular risk. If necessary, pharmacological treatment will be prescribed. Twelve months after the first intervention, a second evaluation on cardiovascular risk and the effectiveness of the intervention will be performed.

Conditions

• Severe Mental Illness
• Schizophrenia
• Bipolar Disorder
• Affective Disorders
• Schizoaffective Disorder
• Personality Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle counseling	Depending on the results of cardiovascular risk factor indexes, the treatment (including drugs, if needed) may be modified or adjusted. A nurse visit will be programmed to explain the lifestyle behaviour the patient should have.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-08-01
• Completion: 2012-12-01
• First posted: 2010-08-16
• Last updated: 2010-08-16

Locations

1 site across 1 country: Spain