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

Consorci Hospitalari de Vic

Status and phase: Unknown; Phase 4

Conditions: Severe Mental Illness; Personality Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder; Affective Disorders

Treatments: Behavioral: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01182012

CVD-SMI-2009-03

Details and patient eligibility

About

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.

Enrollment: 391 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

391 participants in 1 patient group

Lifestyle counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle counseling