Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Changes in global cardiovascular risk
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in global cardiovascular risk
Time Frame: 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 Outcomes
- Stopping tobacco(At six months)
- Changes in systolic/diastolic blood pressure(At six months)
- Changes in cholesterolemia level and other lipids in blood(At six months)
- Changes in glycated haemoglobin(At six months)
Investigators
Dr. Pere Roura-Poch
Epidemiologist
Consorci Hospitalari de Vic