Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)

Schizophrenia Clinical Trial

— PRISCA  

Official title:

Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276012
• Other study ID #: AC-274
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: September 2020
• Source: Consorci Hospitalari de Vic
• Contact: Núria Riera Molist
• Phone: +34937027713
• Email: nriera[@]chv.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective is to determine the effectiveness of a program which consists of multidisciplinary, intensive and individualized interventions, carried out by a group of health professionals (psychiatrist, psychologist, mental health nurse, primary care doctors, pharmacist), during six-month, to improve the global cardiovascular risk (CVR) in patients with schizophrenia. Secondarily, will be analyzed the effectiveness of this program on improving the control in four selected cardiovascular risk factors: hypertension, hypercholesterolemia, hyperglycaemia and smoking, after 6 months Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible patients will be 130 adult (≥18 years) outpatients with a current diagnosis of schizophrenia who follow-up by health mental network in Catalonia, who presents at least bad control in one of the four selected cardiovascular risk factors. The intervention group will receive a multidisciplinary and individualized approach (psychoeducational, recommendations of life style and diet, medication adherence and changes in pharmacological strategy, depending on the individual needs assessing after cardiovascular risk screening. The control group will follow the standard management according to the primary care professionals' team.

Main measurements: the global CVR at baseline and at six-month follow-up through Framingham tables calibrated for the Catalan population (Registre Gironí del Cor, REGICOR). Secondary measures: they will be determined, at baseline and at six-month follow-up, four cardiovascular risk factors as well: hypertension, hypercholesterolemia, hyperglycaemia and smoking, according with the latest recommendations of the Program of preventive activities and health promotion (PAPPS) of the Spanish Society of Family and Community Medicine. Other measures: anthropometric parameters. Functional Assessment Screening Tool (FAST) and quality of life (EQ-5D).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 28, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

adults (=18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.

Exclusion Criteria:

other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Schizophrenia

Intervention

Other:
• Multifactorial intervention
Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy

Locations

Country	Name	City	State
Spain	Vic Hospital Consortium	Vic	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Pere Roura-Poch

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in global cardiovascular risk	Framingham tables calibrated for the Catalan population (Registre Gironí del Cor, REGICOR). The CVR was stratified into the following groups:<5%, low; 5-9%, moderate; 10-14%, high; and =15, very high.	At six months
Secondary	Changes in systolic/diastolic blood pressure	mmHg	At six months
Secondary	Changes in glycated haemoglobin	Percentage of	At six months
Secondary	Changes in cholesterolemia level and other lipids in blood	mg/dL	At six months
Secondary	Stopping tobacco	Yes/No	At six months