Viewing Study NCT04276012



Ignite Creation Date: 2024-05-06 @ 2:18 PM
Last Modification Date: 2024-10-26 @ 1:28 PM
Study NCT ID: NCT04276012
Status: UNKNOWN
Last Update Posted: 2020-09-16
First Post: 2020-02-17

Brief Title: Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia PRISCA
Sponsor: Dr Pere Roura-Poch
Organization: Consorci Hospitalari de Vic

Study Overview

Official Title: Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia PRISCA Study
Status: UNKNOWN
Status Verified Date: 2020-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PRISCA
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 GironĂ­ 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None