Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA) (PRISCA)
Primary Purpose
Schizophrenia, Cardiovascular Risk Factor
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multifactorial intervention
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Vic Hospital ConsortiumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm 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)
Usual clinical care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in systolic/diastolic blood pressure
mmHg
Changes in glycated haemoglobin
Percentage of
Changes in cholesterolemia level and other lipids in blood
mg/dL
Stopping tobacco
Yes/No
Full Information
NCT ID
NCT04276012
First Posted
February 17, 2020
Last Updated
September 14, 2020
Sponsor
Dr. Pere Roura-Poch
1. Study Identification
Unique Protocol Identification Number
NCT04276012
Brief Title
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)
Acronym
PRISCA
Official Title
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Pere Roura-Poch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm 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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual clinical care
Intervention Type
Other
Intervention Name(s)
Multifactorial intervention
Intervention Description
Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy
Primary Outcome Measure Information:
Title
Changes in global cardiovascular risk
Description
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.
Time Frame
At six months
Secondary Outcome Measure Information:
Title
Changes in systolic/diastolic blood pressure
Description
mmHg
Time Frame
At six months
Title
Changes in glycated haemoglobin
Description
Percentage of
Time Frame
At six months
Title
Changes in cholesterolemia level and other lipids in blood
Description
mg/dL
Time Frame
At six months
Title
Stopping tobacco
Description
Yes/No
Time Frame
At six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Núria Riera Molist
Phone
+34937027713
Email
nriera@chv.cat
Facility Information:
Facility Name
Vic Hospital Consortium
City
Vic
State/Province
Catalonia
ZIP/Postal Code
08500
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Núria Riera-Molist, PhD Student
Phone
+34937027772
Email
nriera@chv.cat
First Name & Middle Initial & Last Name & Degree
Núria Riera-Molist, PhD Student
First Name & Middle Initial & Last Name & Degree
Quintí Foguet-Boreu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Santiago García-Eslava, MD
First Name & Middle Initial & Last Name & Degree
Montse Serra-Millas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Montse Assens-Tauste, ND
First Name & Middle Initial & Last Name & Degree
Pere Roura-Poch, MD
First Name & Middle Initial & Last Name & Degree
Neus Frau-Rosello, MD
First Name & Middle Initial & Last Name & Degree
Estefania Gallego-Peña, MD
First Name & Middle Initial & Last Name & Degree
Josep Manel Santos-Lopez, PhD
First Name & Middle Initial & Last Name & Degree
Luis Ayerbe, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marta Guimera-Gallent, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)
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