Reduction of Cardiovascular Risk in Severe Mental Illness

NCT01182012 — Phase 4, Unknown, 391 participants, Consorci Hospitalari de Vic

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Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs

Registry	NCT01182012, acronym RISCA-TMS
Status	Unknown
Phase	Phase 4
Study type	Interventional; non randomized, single group, masking: none, prevention
Enrollment	391 (Estimated)
Sponsor	Consorci Hospitalari de Vic (Other); collaborators: Institut Catala de Salut
Conditions	Severe Mental Illness, Schizophrenia, Bipolar Disorder, Affective Disorders, Schizoaffective Disorder, Personality Disorder
Interventions	Lifestyle counseling (Behavioral)
Dates	start 2010-08-01, primary completion 2011-08-01 (estimated), completion 2012-12-01 (estimated), first posted 2010-08-16, last updated 2010-08-16
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lifestyle counseling	Experimental	Behavioral: 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.

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.

+Outcome measures

Primary outcomes

Reduction of cardiovascular risk [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 outcomes

Normalization of blood pressure [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.
Normalization of cholesterolemia [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.
Control of hiperglycaemia [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.
Smoking cessation [After one year of inclusion]: At the end of follow-up an study about smoking cessation will be made.
Euro-Qol index [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.
Seville quality of life questionnaire (SQLQ) [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

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Vic Hospital Consortium - Consorci Hospitalari de Vic	Vic, Catalonia	Spain	Recruiting

+Publications

Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169. PMID 8521931
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
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
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
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

+Investigators

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

My Notes

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