Clinical trial NCT01182012: Reduction of Cardiovascular Risk in Severe Mental Illness
Official title: Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
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
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
First posted: 2010-08-16
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Reduction of cardiovascular risk
timeFrame: After one year of inclusion
Secondary outcomes:
measure: Normalization of blood pressure
timeFrame: After one year of inclusion
measure: Normalization of cholesterolemia
timeFrame: After one year of inclusion
measure: Control of hiperglycaemia
timeFrame: After one year of inclusion
measure: Smoking cessation
timeFrame: After one year of inclusion
measure: Euro-Qol index
timeFrame: After one year of inclusion
measure: Seville quality of life questionnaire (SQLQ)
timeFrame: After one year of inclusion
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Vic Hospital Consortium - Consorci Hospitalari de Vic
state: Catalonia
Study officials:
affiliation: Vic Hospital Consortium - Consorci Hospitalari de Vic
name: Quintí Foguet-Boreu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.
citation: 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.
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. doi: 10.1002/j.2051-5545.2009.tb00196.x. No abstract available.
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.
citation: 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.