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

D

Dr. Pere Roura-Poch

Status

Unknown

Conditions

Schizophrenia
Cardiovascular Risk Factor

Treatments

Other: Multifactorial intervention

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

130 participants in 2 patient groups

Intervention group
Experimental group
Description:
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)
Treatment:
Other: Multifactorial intervention
Control group
No Intervention group
Description:
Usual clinical care

Trial contacts and locations

1

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Central trial contact

Núria Riera Molist

Data sourced from clinicaltrials.gov

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