- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276012
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA) (PRISCA)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-274
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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