SchizophreniaPRISCANCT04276012
Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia (PRISCA)
A study testing Multifactorial intervention in people with Schizophrenia and Cardiovascular Risk Factor, run by Dr. Pere Roura-Poch at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Cardiovascular Risk Factor
- What is being tested?
- Multifactorial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.
Who cannot join
- other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vic Hospital Consortium
Vic, Catalonia, 08500
Núria Riera-Molist, PhD Student, +34937027772, nriera@chv.cat
Núria Riera-Molist, PhD Student
About this study
Official title: 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).
- Conditions
- Schizophrenia, Cardiovascular Risk Factor
- Being tested
- Multifactorial intervention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial interventionOther
Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Multifactorial intervention |
| Control group | No intervention | Usual clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At six months
Secondary outcomes (4)
Changes in systolic/diastolic blood pressure
mmHg
Measured: At six months
Changes in glycated haemoglobin
Percentage of
Measured: At six months
Changes in cholesterolemia level and other lipids in blood
mg/dL
Measured: At six months
Stopping tobacco
Yes/No
Measured: At six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start20 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Pere Roura-Poch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Pere Roura-Poch, Consorci Hospitalari de Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276012
- Sponsor's protocol ID
- AC-274
- Acronym
- PRISCA
- Status last verified
- Sep 2020
- First submitted
- 17 Feb 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37948170
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cardiovascular Risk Intervention Program in Patients With Schizophrenia: PRISCA Study
- ClinicalTrials.gov ID
- NCT04276012
- Acronym / sponsor ID
- PRISCA / AC-274
- Conditions
- Schizophrenia, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Dr. Pere Roura-PochUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Multifactorial interventionThe 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) |
| Control group | No intervention | –Usual clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults (≥18 years of age), outpatient, current diagnostic of schizophrenia, follow-up by mental health network in Catalonia, signed informed consent.
Key exclusion criteria (1 listed)
- other severe mental illnesses different from schizophrenia, patients with intellectual disabilities or clinical acute psychotic relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifactorial interventionPsychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy | Other | Intervention group |
Primary outcome
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.
4 secondary outcomes
Changes in systolic/diastolic blood pressure
Time frame: At six months
Changes in glycated haemoglobin
Time frame: At six months
Changes in cholesterolemia level and other lipids in blood
Time frame: At six months
Stopping tobacco
Time frame: At six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 37948170Riera-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial intervention in people with Schizophrenia and Cardiovascular Risk Factor, run by Dr. Pere Roura-Poch at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Núria Riera Molist (+34937027713, nriera@chv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in global cardiovascular risk (time frame: At six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276012, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.