Trial record 5 of 14322 for:    mental illness

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Consorci Hospitalari de Vic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institut Catala de Salut
Information provided by:
Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier:
NCT01182012
First received: August 11, 2010
Last updated: August 13, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Consorci Hospitalari de Vic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182012

Contacts
Contact: Pere Roura-Poch, MD +34.937.02.77.13 proura@chv.cat

Locations
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         
Sponsors and Collaborators
Consorci Hospitalari de Vic
Institut Catala de Salut
Investigators
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:
Mental Disorders
Bipolar Disorder
Personality Disorders
Psychotic Disorders
Schizophrenia
Mood Disorders
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 17, 2014