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

September 14, 2020 updated by: Dr. Pere Roura-Poch

Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study

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 Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Núria Riera Molist
  • Phone Number: +34937027713
  • Email: nriera@chv.cat

Study Locations

    • Catalonia
      • Vic, Catalonia, Spain, 08500
        • Recruiting
        • Vic Hospital Consortium
        • Contact:
          • Núria Riera-Molist, PhD Student
          • Phone Number: +34937027772
          • Email: nriera@chv.cat
        • Principal Investigator:
          • Núria Riera-Molist, PhD Student
        • Sub-Investigator:
          • Quintí Foguet-Boreu, MD, PhD
        • Sub-Investigator:
          • Santiago García-Eslava, MD
        • Sub-Investigator:
          • Montse Serra-Millas, MD, PhD
        • Sub-Investigator:
          • Montse Assens-Tauste, ND
        • Sub-Investigator:
          • Neus Frau-Rosello, MD
        • Sub-Investigator:
          • Estefania Gallego-Peña, MD
        • Sub-Investigator:
          • Josep Manel Santos-Lopez, PhD
        • Sub-Investigator:
          • Luis Ayerbe, MD, PhD
        • Sub-Investigator:
          • Marta Guimera-Gallent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
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)
Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy
NO_INTERVENTION: Control group
Usual clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic/diastolic blood pressure
Time Frame: At six months
mmHg
At six months
Changes in glycated haemoglobin
Time Frame: At six months
Percentage of
At six months
Changes in cholesterolemia level and other lipids in blood
Time Frame: At six months
mg/dL
At six months
Stopping tobacco
Time Frame: At six months
Yes/No
At six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

February 28, 2021

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (ACTUAL)

February 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AC-274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Multifactorial intervention

3
Subscribe