Reduction of Cardiovascular Risk in Severe Mental Illness (RISCA-TMS)
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|ClinicalTrials.gov Identifier: NCT01182012|
Recruitment Status : Unknown
Verified August 2010 by Consorci Hospitalari de Vic.
Recruitment status was: Recruiting
First Posted : August 16, 2010
Last Update Posted : August 16, 2010
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Mental Illness Schizophrenia Bipolar Disorder Affective Disorders Schizoaffective Disorder Personality Disorder||Behavioral: Lifestyle counseling||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||391 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||December 2012|
Experimental: 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.
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 [ 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.
- Normalization of blood pressure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After one year of inclusion ]At the end of follow-up an study about smoking cessation will be made.
- Euro-Qol index [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182012
|Contact: Pere Roura-Poch, MDfirstname.lastname@example.org|
|Vic Hospital Consortium - Consorci Hospitalari de Vic||Recruiting|
|Vic, Catalonia, Spain, 08500|
|Sub-Investigator: Anna Bullón-Chia, MD|
|Sub-Investigator: Pere Roura-Poch, MD|
|Sub-Investigator: Cristina Mauri-Martin, Nurse|
|Sub-Investigator: Núria Gordo-Serra, Nurse|
|Sub-Investigator: Raquel Cecilia-Costa, MD|
|Principal Investigator:||Quintí Foguet-Boreu, MD, PhD||Vic Hospital Consortium - Consorci Hospitalari de Vic|