Reduction of Cardiovascular Risk in Severe Mental Illness

Phase 4

• Conditions: Severe Mental Illness; Schizophrenia; Bipolar Disorder; Affective Disorders; Schizoaffective Disorder; Personality Disorder
• Interventions: Behavioral: Lifestyle counseling

• Registration Number: NCT01182012
• Lead Sponsor: Consorci Hospitalari de Vic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-13
• Last Update Submitted: 2010-08-13
• Study First Posted: 2010-08-16
• Last Update Posted: 2010-08-16
• Primary Completion: 2011-08
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 391

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle counseling	Adjust drug treatment to control cardiovascular factor risks. A nurse will implement a lifestyle counseling in order to improve compliance of treatment and a healthy lifestyle.

Primary Outcome Measures

Name	Time	Method
Reduction of cardiovascular risk	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 Outcome Measures

Name	Time	Method
Normalization of blood pressure	After one year of inclusion	An analysis will be made to see if initial abnormal blood pressure levels have been normalized at the end of study.
Normalization of cholesterolemia	After one year of inclusion	An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
Control of hiperglycaemia	After one year of inclusion	An analysis will be made to see if initial abnormal glycose blood levels (and if diabetes was diagnosticated) have been normalized at the end of study.
Smoking cessation	After one year of inclusion	At the end of follow-up an study about smoking cessation will be made.
Euro-Qol index	After one year of inclusion	To compare Euro-Qol index quality of life questionnaire obtained twice, at inclusion and after one year of follow-up.
Seville quality of life questionnaire (SQLQ)	After one year of inclusion	Seville quality of life questionnaire has proven to be a valid sensitive instrument to measure quality of life in schizophrenic patients. It focuses on aspects that are relevant for patients that were frequently overlooked by treating physicians. To compare SQLQ index obtained twice, at inclusion and after one year of follow-up.

Trial Locations

Locations (1)

Vic Hospital Consortium - Consorci Hospitalari de Vic; 🇪🇸 Vic, Catalonia, Spain