NCT04276012: PRISCA

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

Status unknown NA Last updated 16 September 2020

What this trial tests

NA trial testing Multifactorial intervention in Schizophrenia in 130 participants. Status unknown.

Timeline

20 January 2020

Primary endpoint
31 December 2020

28 February 2021

Quick facts

Lead sponsor	Dr. Pere Roura-Poch
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	130
Start date	20 January 2020
Primary completion	31 December 2020
Estimated completion	28 February 2021
Sites	1 location across Spain

Drugs / interventions tested

• Multifactorial intervention

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

Dr. Pere Roura-Poch

Who can join

18 and older, any sex, with Schizophrenia or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Cardiovascular Risk Optimization Program in People With Schizophrenia: A Pilot Randomized Controlled Clinical Trial.
   Riera-Molist N, Assens-Tauste M, Roura-Poch P, Guimerà-Gallent M, et al · · 2023 · cited 1× · PMID 37948170 · DOI 10.1097/pra.0000000000000743