Reduction of Cardiovascular Risk in Severe Mental Illness (RISCA-TMS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Severe Mental Illness; Schizophrenia; Bipolar Disorder; Affective Disorders; Schizoaffective Disorder; Personality Disorder	Behavioral: Lifestyle counseling	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	391 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. Smoking cessation [ Time Frame: After one year of inclusion ]
   At the end of follow-up an study about smoking cessation will be made.
5. 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.
6. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Pere Roura-Poch, MD	+34.937.02.77.13	proura@chv.cat

Locations

Spain
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

Sponsors and Collaborators

Consorci Hospitalari de Vic

Institut Catala de Salut

Investigators

Principal Investigator:	Quintí Foguet-Boreu, MD, PhD	Vic Hospital Consortium - Consorci Hospitalari de Vic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Cardiovascular risk in severe mental illness 

Publications:

Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. Review.

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.

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.

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.

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.

Responsible Party:	Quintí Foguet-Boreu, MD & PhD, Vic Hospital Consortium - Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier:	NCT01182012 History of Changes
Other Study ID Numbers:	CVD-SMI-2009-03
First Posted:	August 16, 2010
Last Update Posted:	August 16, 2010
Last Verified:	August 2010

Keywords provided by Consorci Hospitalari de Vic:

Cardiovascular risk factor; Severe mental illness; Drug appropriateness; Drug compliance; Lifestyle counseling

Additional relevant MeSH terms:

Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Personality Disorders	Mental Disorders; Mood Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders