Reduction of Cardiovascular Risk in Severe Mental Illness (RISCA-TMS)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Mental Illness Schizophrenia Bipolar Disorder Affective Disorders Schizoaffective Disorder Personality Disorder |
Behavioral: Lifestyle counseling |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs |
- Reduction of cardiovascular risk [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]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.
- Normalization of blood pressure [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]An analysis will be made to see if initial abnormal blood pressure levels have been normalized at the end of study.
- Normalization of cholesterolemia [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
- Control of hiperglycaemia [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]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 [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]At the end of follow-up an study about smoking cessation will be made.
- Euro-Qol index [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]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) [ Time Frame: After one year of inclusion ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 391 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01182012
| Contact: Pere Roura-Poch, MD | +34.937.02.77.13 | proura@chv.cat |
| Spain | |
| Vic Hospital Consortium - Consorci Hospitalari de Vic | Recruiting |
| Vic, Catalonia, Spain, 08500 | |
| Sub-Investigator: Anna Bullón-Chia, MD | |
| Sub-Investigator: Pere Roura-Poch, MD | |
| Sub-Investigator: Cristina Mauri-Martin, Nurse | |
| Sub-Investigator: Núria Gordo-Serra, Nurse | |
| Sub-Investigator: Raquel Cecilia-Costa, MD | |
| Principal Investigator: | Quintí Foguet-Boreu, MD, PhD | Vic Hospital Consortium - Consorci Hospitalari de Vic |
More Information
Additional Information:
Publications:
| Responsible Party: | Quintí Foguet-Boreu, MD & PhD, Vic Hospital Consortium - Consorci Hospitalari de Vic |
| ClinicalTrials.gov Identifier: | NCT01182012 History of Changes |
| Other Study ID Numbers: | CVD-SMI-2009-03 |
| Study First Received: | August 11, 2010 |
| Last Updated: | August 13, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Consorci Hospitalari de Vic:
|
Cardiovascular risk factor Severe mental illness Drug appropriateness Drug compliance Lifestyle counseling |
Additional relevant MeSH terms:
|
Disease Mental Disorders Personality Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on February 27, 2015