Schizophrenia Clinical Trial
— RISCA-TMSOfficial title:
Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs
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.
Status | Recruiting |
Enrollment | 391 |
Est. completion date | December 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Vic Hospital Consortium - Consorci Hospitalari de Vic | Vic | Catalonia |
Lead Sponsor | Collaborator |
---|---|
Consorci Hospitalari de Vic | Institut Catala de Salut |
Spain,
Gold KJ, Kilbourne AM, Valenstein M. Primary care of patients with serious mental illness: your chance to make a difference. J Fam Pract. 2008 Aug;57(8):515-25. Review. — View Citation
Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. Review. — View Citation
Heald A, Montejo AL, Millar H, De Hert M, McCrae J, Correll CU. Management of physical health in patients with schizophrenia: practical recommendations. Eur Psychiatry. 2010 Jun;25 Suppl 2:S41-5. doi: 10.1016/S0924-9338(10)71706-5. — View Citation
Maj M. Physical health care in persons with severe mental illness: a public health and ethical priority. World Psychiatry. 2009 Feb;8(1):1-2. — View Citation
Marrugat J, Solanas P, D'Agostino R, Sullivan L, Ordovas J, Cordón F, Ramos R, Sala J, Masià R, Rohlfs I, Elosua R, Kannel WB. [Coronary risk estimation in Spain using a calibrated Framingham function]. Rev Esp Cardiol. 2003 Mar;56(3):253-61. Spanish. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | After one year of inclusion | No |
Secondary | 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. | After one year of inclusion | No |
Secondary | Normalization of cholesterolemia | An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study. | After one year of inclusion | No |
Secondary | 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. | After one year of inclusion | No |
Secondary | Smoking cessation | At the end of follow-up an study about smoking cessation will be made. | After one year of inclusion | No |
Secondary | Euro-Qol index | To compare Euro-Qol index quality of life questionnaire obtained twice, at inclusion and after one year of follow-up. | After one year of inclusion | No |
Secondary | 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. | After one year of inclusion | No |
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