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

NCT04276012 | Unknown

• 1 other identifier: AC-274
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Changes in global cardiovascular risk

  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 Outcomes (4)

• Changes in systolic/diastolic blood pressure

  At six months

• Changes in glycated haemoglobin

  At six months

• Changes in cholesterolemia level and other lipids in blood

  At six months

• Stopping tobacco

  At six months

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Other: Multifactorial intervention

Control group

NO INTERVENTION

Usual clinical care

Interventions

Multifactorial intervention OTHER

Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.

You may not qualify if:

• other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse

Sponsors & Collaborators

• Dr. Pere Roura-Poch: lead

Study Sites (1)

Vic Hospital Consortium

Vic, Catalonia, 08500, Spain

RECRUITING

Related Publications (1)

• Riera-Molist N, Assens-Tauste M, Roura-Poch P, Guimera-Gallent M, Santos-Lopez JM, Serra-Millas M, Frau-Rossello N, Gallego-Pena E, Foguet-Boreu Q. A Cardiovascular Risk Optimization Program in People With Schizophrenia: A Pilot Randomized Controlled Clinical Trial. J Psychiatr Pract. 2023 Nov 1;29(6):456-468. doi: 10.1097/PRA.0000000000000743.

  PMID: 37948170 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Núria Riera Molist

CONTACT

+34937027713; nriera@chv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Epidemiologist

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: January 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: February 28, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)