A Phase 4 interventional study of Lifestyle counseling in Severe Mental Illness, Schizophrenia and Bipolar Disorder, sponsored by Consorci Hospitalari de Vic. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-08-16.
Sponsored by Consorci Hospitalari de Vic · Phase 4, Interventional, and Prevention
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.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's planned enrollment of 391 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Consorci Hospitalari de Vic is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Reduction of cardiovascular risk
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.
Time frame: After one year of inclusion
Normalization of blood pressure
An analysis will be made to see if initial abnormal blood pressure levels have been normalized at the end of study.
Time frame: After one year of inclusion
Normalization of cholesterolemia
An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
Time frame: After one year of inclusion
Control of hiperglycaemia
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.
Time frame: After one year of inclusion
Smoking cessation
At the end of follow-up an study about smoking cessation will be made.
Time frame: After one year of inclusion
Euro-Qol index
To compare Euro-Qol index quality of life questionnaire obtained twice, at inclusion and after one year of follow-up.
Time frame: After one year of inclusion
Seville quality of life questionnaire (SQLQ)
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.
Time frame: After one year of inclusion
This study is status unknown, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Consorci Hospitalari de Vic