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

Primary Purpose

Severe Mental Illness, Schizophrenia, Bipolar Disorder

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lifestyle counseling
Sponsored by
Consorci Hospitalari de Vic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Mental Illness focused on measuring Cardiovascular risk factor, Severe mental illness, Drug appropriateness, Drug compliance, Lifestyle counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vic Hospital Consortium - Consorci Hospitalari de VicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle counseling

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Normalization of blood pressure
An analysis will be made to see if initial abnormal blood pressure levels have been normalized at the end of study.
Normalization of cholesterolemia
An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
Control of hiperglycaemia
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
At the end of follow-up an study about smoking cessation will be made.
Euro-Qol index
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)
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.

Full Information

First Posted
August 11, 2010
Last Updated
August 13, 2010
Sponsor
Consorci Hospitalari de Vic
Collaborators
Institut Catala de Salut
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1. Study Identification

Unique Protocol Identification Number
NCT01182012
Brief Title
Reduction of Cardiovascular Risk in Severe Mental Illness
Acronym
RISCA-TMS
Official Title
Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Consorci Hospitalari de Vic
Collaborators
Institut Catala de Salut

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
391 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of cardiovascular risk
Description
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.
Time Frame
After one year of inclusion
Secondary Outcome Measure Information:
Title
Normalization of blood pressure
Description
An analysis will be made to see if initial abnormal blood pressure levels have been normalized at the end of study.
Time Frame
After one year of inclusion
Title
Normalization of cholesterolemia
Description
An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
Time Frame
After one year of inclusion
Title
Control of hiperglycaemia
Description
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.
Time Frame
After one year of inclusion
Title
Smoking cessation
Description
At the end of follow-up an study about smoking cessation will be made.
Time Frame
After one year of inclusion
Title
Euro-Qol index
Description
To compare Euro-Qol index quality of life questionnaire obtained twice, at inclusion and after one year of follow-up.
Time Frame
After one year of inclusion
Title
Seville quality of life questionnaire (SQLQ)
Description
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.
Time Frame
After one year of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Roura-Poch, MD
Phone
+34.937.02.77.13
Email
proura@chv.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quintí Foguet-Boreu, MD, PhD
Organizational Affiliation
Vic Hospital Consortium - Consorci Hospitalari de Vic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vic Hospital Consortium - Consorci Hospitalari de Vic
City
Vic
State/Province
Catalonia
ZIP/Postal Code
08500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Bullón-Chia, MD
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD
First Name & Middle Initial & Last Name & Degree
Cristina Mauri-Martin, Nurse
First Name & Middle Initial & Last Name & Degree
Núria Gordo-Serra, Nurse
First Name & Middle Initial & Last Name & Degree
Raquel Cecilia-Costa, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
8521931
Citation
Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.
Results Reference
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PubMed Identifier
18687227
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.
Results Reference
background
PubMed Identifier
19293947
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.
Results Reference
background
PubMed Identifier
20620887
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.
Results Reference
background
PubMed Identifier
12622955
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.
Results Reference
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Links:
URL
http://www.chv.cat
Description
Cardiovascular risk in severe mental illness

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Reduction of Cardiovascular Risk in Severe Mental Illness

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