Reduction of Cardiovascular Risk in Severe Mental Illness

Schizophrenia Clinical Trial

— RISCA-TMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01182012
• Other study ID #: CVD-SMI-2009-03
• Status: Recruiting
• Phase: Phase 4
• First received: August 11, 2010
• Last updated: August 13, 2010
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2010
• Source: Consorci Hospitalari de Vic
• Contact: Pere Roura-Poch, MD
• Phone: +34.937.02.77.13
• Email: proura[@]chv.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Affective Disorders
• Bipolar Disorder
• Disease
• Mental Disorders
• Mood Disorders
• Personality Disorder
• Personality Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Severe Mental Illness

Intervention

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.

Locations

Country	Name	City	State
Spain	Vic Hospital Consortium - Consorci Hospitalari de Vic	Vic	Catalonia

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic	Institut Catala de Salut

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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

Outcome

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

External Links

•   Cardiovascular risk in severe mental illness