Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)
- Conditions
- SchizophreniaCardiovascular Risk Factor
- Interventions
- Other: Multifactorial intervention
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.
other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Multifactorial intervention The intervention group will participate in different intervention strategy depending on the individual needs (psychoeducational, recommendations of life style and diet, medication adherence and changes in pharmacological strategy)
- 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