Reduction of Cardiovascular Risk in Severe Mental Illness

NCT01182012 | Unknown Phase 4 DMC

• 1 other identifier: CVD-SMI-2009-03
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Normalization of blood pressure

  After one year of inclusion

• Normalization of cholesterolemia

  After one year of inclusion

• Control of hiperglycaemia

  After one year of inclusion

• Smoking cessation

  After one year of inclusion

• Euro-Qol index

  After one year of inclusion

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

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

Interventions

Lifestyle counseling BEHAVIORAL

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.

Lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Renal or hepatic failure, metabolic or endocrine disorder
• Patients who do not accept to participate

Sponsors & Collaborators

• Consorci Hospitalari de Vic: lead
• Institut Catala de Salut: collaborator

Study Sites (1)

Vic Hospital Consortium - Consorci Hospitalari de Vic

Vic, Catalonia, 08500, Spain

RECRUITING

Related Publications (5)

• Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.

  PMID: 8521931 BACKGROUND

• 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.

  PMID: 18687227 BACKGROUND

• 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.

  PMID: 19293947 BACKGROUND

• 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.

  PMID: 20620887 BACKGROUND

• 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.

  PMID: 12622955 BACKGROUND

Related Links

• Cardiovascular risk in severe mental illness

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Bipolar Disorder; Mood Disorders; Psychotic Disorders; Personality Disorders; Medication Adherence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Quintí Foguet-Boreu, MD, PhD

  Vic Hospital Consortium - Consorci Hospitalari de Vic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pere Roura-Poch, MD

CONTACT

+34.937.02.77.13; proura@chv.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

ES (1)