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

Not Applicable

• Conditions: Schizophrenia; Cardiovascular Risk Factor

• Registration Number: NCT04276012
• Lead Sponsor: Dr. Pere Roura-Poch

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in global cardiovascular risk	At six months	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.

Secondary Outcome Measures

Name	Time	Method
Stopping tobacco	At six months	Yes/No
Changes in systolic/diastolic blood pressure	At six months	mmHg
Changes in cholesterolemia level and other lipids in blood	At six months	mg/dL
Changes in glycated haemoglobin	At six months	Percentage of

Trial Locations

Locations (1)

Vic Hospital Consortium; 🇪🇸 Vic, Catalonia, Spain