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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Affective Disorders; Personality Disorder; Severe Mental Illness
• Intervention / Treatment: Behavioral: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Anticipated): 391
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Vic, Catalonia, Spain, 08500
      • Recruiting
      • Vic Hospital Consortium - Consorci Hospitalari de Vic
      • Sub-Investigator: Anna Bullón-Chia, MD
      • Sub-Investigator: Cristina Mauri-Martin, Nurse
      • Sub-Investigator: Núria Gordo-Serra, Nurse
      • Sub-Investigator: Raquel Cecilia-Costa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Smoking cessation	At the end of follow-up an study about smoking cessation will be made.	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.	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.	After one year of inclusion

Collaborators and Investigators

• Sponsor: Consorci Hospitalari de Vic
• Collaborators: Institut Catala de Salut
• Investigators: Principal Investigator: Quintí Foguet-Boreu, MD, PhD, Vic Hospital Consortium - Consorci Hospitalari de Vic

Publications and helpful links

General Publications

• Marrugat J, Solanas P, D'Agostino R, Sullivan L, Ordovas J, Cordon F, Ramos R, Sala J, Masia 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. doi: 10.1016/s0300-8932(03)76861-4. Spanish.
• 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. doi: 10.1002/j.2051-5545.2009.tb00196.x. No abstract available.
• Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.
• 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. No abstract available.
• 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.

Helpful Links

• Cardiovascular risk in severe mental illness

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 11, 2010
• First Submitted That Met QC Criteria: August 13, 2010
• First Posted (Estimate): August 16, 2010

Study Record Updates

• Last Update Posted (Estimate): August 16, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Severe mental illness; Cardiovascular risk factor; Drug appropriateness; Drug compliance; Lifestyle counseling
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Personality Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: CVD-SMI-2009-03