Severe Mental IllnessPhase 4RISCA-TMSNCT01182012
Reduction of Cardiovascular Risk in Severe Mental Illness
A Phase 4 study testing Lifestyle counseling in people with Severe Mental Illness and Schizophrenia, run by Consorci Hospitalari de Vic at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Schizophrenia, Bipolar Disorder
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Renal or hepatic failure, metabolic or endocrine disorder
- Patients who do not accept to participate
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vic Hospital Consortium - Consorci Hospitalari de Vic
Vic, Catalonia, 08500
Anna Bullón-Chia, MD
Pere Roura-Poch, MD
About this study
Official title: Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs
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.
Read more
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.
- Conditions
- Severe Mental Illness, Schizophrenia, Bipolar Disorder, Affective Disorders, Schizoaffective Disorder, Personality Disorder
- Being tested
- Lifestyle counseling
- Keywords
- Cardiovascular risk factor, Severe mental illness, Drug appropriateness, Drug compliance, Lifestyle counseling
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Mood Disorders, Psychotic Disorders, Personality Disorders, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | 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. Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After one year of inclusion
Secondary outcomes (6)
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.
Measured: After one year of inclusion
Normalization of cholesterolemia
An analysis will be made to see if initial abnormal cholesterolemia blood levels have been normalized at the end of study.
Measured: After one year of inclusion
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.
Measured: After one year of inclusion
Smoking cessation
At the end of follow-up an study about smoking cessation will be made.
Measured: After one year of inclusion
Euro-Qol index
To compare Euro-Qol index quality of life questionnaire obtained twice, at inclusion and after one year of follow-up.
Measured: After one year of inclusion
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.
Measured: After one year of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 391 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Hospitalari de Vic
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Catala de Salut
- Investigators
- Quintí Foguet-Boreu, MD, PhD, Principal investigator, Vic Hospital Consortium - Consorci Hospitalari de Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182012
- Sponsor's protocol ID
- CVD-SMI-2009-03
- Acronym
- RISCA-TMS
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.
PubMed 8521931Gold 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.
PubMed 18687227Maj 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.
PubMed 19293947Heald 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.
PubMed 20620887Marrugat 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.
PubMed 12622955
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Cardiovascular Risk in Severe Mental Illness Prescribing and Using Better and More Appropriated Drugs
- ClinicalTrials.gov ID
- NCT01182012
- Acronym / sponsor ID
- RISCA-TMS / CVD-SMI-2009-03
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 391 participants (estimated)
- Lead sponsor
- Consorci Hospitalari de VicUniversity, hospital or other
- Collaborators
- Institut Catala de Salut
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 16 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingAdjust 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Renal or hepatic failure, metabolic or endocrine disorder
- Patients who do not accept to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselingDepending 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. | Behavioural | Lifestyle counseling |
Primary outcome
Reduction of cardiovascular risk
Time frame: 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.
6 secondary outcomes
Normalization of blood pressure
Time frame: After one year of inclusion
Normalization of cholesterolemia
Time frame: After one year of inclusion
Control of hiperglycaemia
Time frame: After one year of inclusion
Smoking cessation
Time frame: After one year of inclusion
Euro-Qol index
Time frame: After one year of inclusion
Seville quality of life questionnaire (SQLQ)
Time frame: After one year of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2010.
- Background: PubMed 8521931Hayward C. Psychiatric illness and cardiovascular disease risk. Epidemiol Rev. 1995;17(1):129-38. doi: 10.1093/oxfordjournals.epirev.a036169.
- Background: PubMed 18687227Gold 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.
- Background: PubMed 19293947Maj 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.
- Background: PubMed 20620887Heald 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.
- Background: PubMed 12622955Marrugat 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.
- Cardiovascular risk in severe mental illnessLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quintí Foguet-Boreu, MD, PhD principal investigator
Vic Hospital Consortium - Consorci Hospitalari de Vic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifestyle counseling in people with Severe Mental Illness and Schizophrenia, run by Consorci Hospitalari de Vic at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pere Roura-Poch, MD (+34.937.02.77.13, proura@chv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of cardiovascular risk (time frame: After one year of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182012, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2010.