Clinical trial NCT04276012: Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)
Official title: Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Cardiovascular Risk Factor
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Changes in global cardiovascular risk
timeFrame: At six months
Secondary outcomes:
measure: Changes in systolic/diastolic blood pressure
timeFrame: At six months
measure: Changes in glycated haemoglobin
timeFrame: At six months
measure: Changes in cholesterolemia level and other lipids in blood
timeFrame: At six months
measure: Stopping tobacco
timeFrame: At six months
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Vic Hospital Consortium
state: Catalonia
Study officials:
References: