Skip to main content
Clinical Trials/NCT01182012
NCT01182012
Unknown
Phase 4

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

Consorci Hospitalari de Vic1 site in 1 country391 target enrollmentAugust 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Severe Mental Illness
Sponsor
Consorci Hospitalari de Vic
Enrollment
391
Locations
1
Primary Endpoint
Reduction of cardiovascular risk
Last Updated
15 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with a severe mental illness as schizophrenia, bipolar disorder, affective disorder, schizoaffective disorder or personality disorder and others who receive clinical follow-up in Osona (a county) mental health center.
  • Inclusion will be delayed in patients with acute psychiatric symptoms.

Exclusion Criteria

  • Renal or hepatic failure, metabolic or endocrine disorder
  • Patients who do not accept to participate

Outcomes

Primary Outcomes

Reduction of cardiovascular risk

Time Frame: After one year of inclusion

To collect the Systematic coronary risk evaluation (SCORE) index adapted for low-risk countries and the REGICOR index (an adaptation on the Framingham cardiovascular risk function) for each patient twice at inclusion and after one year of follow-up. To calculate and to analyse the changes between the two moments.

Secondary Outcomes

  • Normalization of blood pressure(After one year of inclusion)
  • Normalization of cholesterolemia(After one year of inclusion)
  • Control of hiperglycaemia(After one year of inclusion)
  • Smoking cessation(After one year of inclusion)
  • Euro-Qol index(After one year of inclusion)
  • Seville quality of life questionnaire (SQLQ)(After one year of inclusion)

Study Sites (1)

Loading locations...

Similar Trials