Primary PreventionProSALUTENCT03129165
ProSALUTE: Community Program for Cardiovascular Health
A study testing Screening and prevention of CVD in people with Primary Prevention, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
The purpose of this study is to determine the efficacy and cost/effectiveness (change in CV risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV prevention. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Screening and prevention of CVD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2015to 11 May 2018
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Live in Milan at neighborhood of Ponte Lambro
Who cannot join
- Patients with known atherosclerotic disease (secondary prevention)
- Severe diseases or disabilities that hinder the participation in the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ProSALUTE: a New Community Program for Cardiovascular Health
The purpose of this study is to determine the efficacy and cost/effectiveness (change in CV risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV prevention.
Read the detailed description
Primary Cardiovascular (CV) prevention programs in the healthcare place and community-based interventions have a variable impact on health at the population level. The largest benefit may be obtained by addressing high-risk, disadvantaged and traditionally hard-to-reach groups.
Effective actions include health promotion, timely screening of modifiable risk factors, application of evidence-based targets and interventions, broad access to heart-friendly environments/facilities and dissemination of favorable social norms. Thus, community prevention is a multifaceted task that requires multidisciplinary collaboration. A suitable program should be tailored to the specific social context and make the most of local resources to improve access, adherence and continuity, as well as sustainability.
ProSALUTE is a new model of primary CV prevention for the prevalently low-income and multiethnic community of Ponte Lambro (n=3600 adults), the neighborhood where the coordinating hospital (Centro Cardiologico Monzino, Milan, Italy) is located.
Under the coordination of a Case Manager (a Nursing Researcher) the citizens are involved in a prevention program, which is personalized (content and intensity) according to the individual global risk and specific risk factors. The citizens follow an individualized schedule of short-term specialist care. Besides, the participants are "gently nudged" to make use of local resources that may contribute to sustain a healthy life-style (e.g. parks, gyms, social services, etc). Moreover, public preventive events for the community are devised (e.g. healthy-cooking course, walking groups, etc) through a collaborative network with representatives of the neighborhood.
- Conditions
- Primary Prevention
- Being tested
- Screening and prevention of CVD
- Keywords
- Cardiovascular diseases, Public Health, Hypertension, Smoking, Hypercholesterolemia, Food Habits, Exercise, Anxiety, Depression, Obesity, Diabetes
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Smoking, Hypercholesterolemia, Feeding Behavior, Motor Activity, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and prevention of CVDOther
Drug: Pharmacological control of risk factors in agreement with primary physicians.
Behavioral: Smoking cessation / Control of depression and anxiety / Nutritional counseling / Motivation for physical activity.
Social: Social worker care.
| Study group | Role | What they receive |
|---|---|---|
| Screening and prevention of CVD | Experimental | Not described Receives: Other: Screening and prevention of CVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary adherence at baseline screening
Primary adherence evaluated as the ratio between the number of subjects enrolled and the number of subjects actively contacted through personal postal mail
Measured: Baseline
Secondary outcomes (22)
Influence of education level on primary adherence
Assessed as rate of primary adherence according to educational level (years of schooling <8, 8-12 or >12)
Measured: Baseline
Influence of working category on primary adherence
Assessed as rate of primary adherence according to working category (manual worker, service worker, office worker, unemployed, retired)
Measured: Baseline
Influence of immigrant or native status on primary adherence
Assessed as rate of primary adherence according to immigrant (from any country) or native status
Measured: Baseline
Awareness of own cardiovascular risk factors
Awareness assessed as prevalence of knowledge (answer: known value or not known) of levels of the following personal cardiovascular risk factors: total cholesterol, triglycerides, glycaemia, systolic and diastolic blood pressure
Measured: Baseline
Accuracy of the perception of own cardiovascular risk
Accuracy assessed as concordance (using Cohen's kappa test) between risk perception (evaluated through a 5 point Likert scale questionnaire: from very low to very high) and estimated cardiovascular risk (evaluated through the Framingham Risk Score)
Measured: Baseline
Prevalence of positive screening for anxiety
Anxiety assessed using General Anxiety Disorder 2 (GAD-2) test and defined as positive with a score ≥3
Measured: Baseline
Prevalence of positive screening for depression
Depressive mood assessed using Patient Health Questionnaire 2 (PHQ-2) test and defined as positive with a score ≥3
Measured: Baseline
Extent of adherence to the Mediterranean Diet (MD)
Extent of adherence to MD assessed using the PREDIMED questionnaire and score, using three categories (0-7 low adherence; 8-9 medium adherence, ≥10 high adherence)
Measured: Baseline
Prevalence of physically active subjects
Physical activity (PA) assessed using the PASSI questionnaire and physically active subjects defined according to the WHO 2010 Guidelines
Measured: Baseline
Human resources utilization
Percent of enrolled subjects allocated to medical visit, interview with nutritionist, motivational interview to promote physical activity, smoking-cessation program, interview with psychologist
Measured: Baseline
Persistence in the program at 6th months
Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled
Measured: 6 months
Changes in adherence to MD at 6 months
Assessed as the net improvement in category of adherence to MD (number of those who increased minus number of those who decreased)
Measured: 6 months
Changes in PA at 6 months
Assessed as the net improvement in category of PA level (number of sedentary subjects shifted to active or moderate minus number of active or moderate shifted to sedentary)
Measured: 6 months
Changes in declared cigarette consumption
Assessed as the net improvement in extent of cigarette consumption (number of smokers who reduced the number of cigarettes/day minus number of smokers who increased the number of cigarettes/day)
Measured: 6 months
Changes in objective measures of cigarette smoke exposure
Assessed as the net improvement in exhaled Carbon Monoxide (CO) (number of smokers who reduced ≥10% exhaled CO ppm minus number of smokers who increased ≥10% exhaled CO ppm)
Measured: 6 months
Change in positive screening for anxiety
Assessed as the net improvement in screening for anxiety (number of positive who became negative minus number of negative who became positive)
Measured: 6 months
Change in positive screening for depression
Assessed as the net improvement in screening for depression (number of positive who became negative minus number of negative who became positive)
Measured: 6 months
Global change in traditional risk factors at 6th months
Assessed as the number of subjects who improved by ≥10% at least one traditional CV risk factor measure without worsening by ≥10% any other CV risk factor measure. The CV risk factors considered are: glycaemia >126 mg/dl, LDL-C >115 mg/dl, systolic blood pressure >140 mmHg and BMI >28
Measured: 6 months
Global change in estimated risk at 6th months
Assessed as net improvement in Framingham Risk Score (number of subjects who reduced the score minus number of subjects who increased the score)
Measured: 6 months
Persistence in the program at 12th months
Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled
Measured: 12 months
Global change in traditional risk factors at 12th months
Assessed as the number of subjects who improved by ≥10% at least one traditional CV risk factor measure without worsening by ≥10% any other CV risk factor measure. The CV risk factors considered are: glycaemia >126 mg/dl, LDL-C >115 mg/dl, systolic blood pressure >140 mmHg and BMI >28
Measured: 12 months
Global change in estimated risk at 12th months
Assessed as net improvement in Framingham Risk Score (number of subjects who reduced the score minus number of subjects who increased the score)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start11 May 2015
- Primary completion11 May 2018 (estimated)
- Study completion11 May 2018 (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 Primary PreventionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Pablo Werba, Centro Cardiologico Monzino
- Investigators
- José Pablo P Werba, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129165
- Sponsor's protocol ID
- R212/15 - CCM 226
- Acronym
- ProSALUTE
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Werba JP, Giroli MG, Simonelli N, Vigo L, Gorini A, Bonomi A, Veglia F, Tremoli E. Uptake and effectiveness of a primary cardiovascular prevention program in an underserved multiethnic urban community. Nutr Metab Cardiovasc Dis. 2022 May;32(5):1110-1120. doi: 10.1016/j.numecd.2022.01.013. Epub 2022 Jan 16.
PubMed 35260313
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProSALUTE: a New Community Program for Cardiovascular Health
- ClinicalTrials.gov ID
- NCT03129165
- Acronym / sponsor ID
- ProSALUTE / R212/15 - CCM 226
- Conditions
- Primary Prevention
- Keywords
- Cardiovascular diseases, Public Health, Hypertension, Smoking, Hypercholesterolemia, Food Habits, Exercise, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- 11 May 2015 (actual)
- Primary completion
- 11 May 2018 (estimated)
- Study completion
- 11 May 2018 (estimated)
- First posted
- 26 Apr 2017 (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 purpose of this study is to determine the efficacy and cost/effectiveness (change in CV risk factors and lifestyle vs costs) of ProSALUTE as a new organizational model of primary CV prevention.
Detailed description
Primary Cardiovascular (CV) prevention programs in the healthcare place and community-based interventions have a variable impact on health at the population level. The largest benefit may be obtained by addressing high-risk, disadvantaged and traditionally hard-to-reach groups.
Effective actions include health promotion, timely screening of modifiable risk factors, application of evidence-based targets and interventions, broad access to heart-friendly environments/facilities and dissemination of favorable social norms. Thus, community prevention is a multifaceted task that requires multidisciplinary collaboration. A suitable program should be tailored to the specific social context and make the most of local resources to improve access, adherence and continuity, as well as sustainability.
ProSALUTE is a new model of primary CV prevention for the prevalently low-income and multiethnic community of Ponte Lambro (n=3600 adults), the neighborhood where the coordinating hospital (Centro Cardiologico Monzino, Milan, Italy) is located.
Under the coordination of a Case Manager (a Nursing Researcher) the citizens are involved in a prevention program, which is personalized (content and intensity) according to the individual global risk and specific risk factors. The citizens follow an individualized schedule of short-term specialist care. Besides, the participants are "gently nudged" to make use of local resources that may contribute to sustain a healthy life-style (e.g. parks, gyms, social services, etc). Moreover, public preventive events for the community are devised (e.g. healthy-cooking course, walking groups, etc) through a collaborative network with representatives of the neighborhood.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening and prevention of CVD | Experimental | Other: Screening and prevention of CVD |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Live in Milan at neighborhood of Ponte Lambro
Key exclusion criteria (2 listed)
- Patients with known atherosclerotic disease (secondary prevention)
- Severe diseases or disabilities that hinder the participation in the program
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 |
|---|---|---|
| Screening and prevention of CVDDrug: Pharmacological control of risk factors in agreement with primary physicians. Behavioral: Smoking cessation / Control of depression and anxiety / Nutritional counseling / Motivation for physical activity. Social: Social worker care. | Other | Screening and prevention of CVD |
Primary outcome
Primary adherence at baseline screening
Time frame: Baseline
Primary adherence evaluated as the ratio between the number of subjects enrolled and the number of subjects actively contacted through personal postal mail
22 secondary outcomes
Influence of education level on primary adherence
Time frame: Baseline
Influence of working category on primary adherence
Time frame: Baseline
Influence of immigrant or native status on primary adherence
Time frame: Baseline
Awareness of own cardiovascular risk factors
Time frame: Baseline
Accuracy of the perception of own cardiovascular risk
Time frame: Baseline
Prevalence of positive screening for anxiety
Time frame: Baseline
Prevalence of positive screening for depression
Time frame: Baseline
Extent of adherence to the Mediterranean Diet (MD)
Time frame: Baseline
Prevalence of physically active subjects
Time frame: Baseline
Human resources utilization
Time frame: Baseline
Persistence in the program at 6th months
Time frame: 6 months
Changes in adherence to MD at 6 months
Time frame: 6 months
Changes in PA at 6 months
Time frame: 6 months
Changes in declared cigarette consumption
Time frame: 6 months
Changes in objective measures of cigarette smoke exposure
Time frame: 6 months
Change in positive screening for anxiety
Time frame: 6 months
Change in positive screening for depression
Time frame: 6 months
Global change in traditional risk factors at 6th months
Time frame: 6 months
Global change in estimated risk at 6th months
Time frame: 6 months
Persistence in the program at 12th months
Time frame: 12 months
Global change in traditional risk factors at 12th months
Time frame: 12 months
Global change in estimated risk at 12th months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 35260313Werba JP, Giroli MG, Simonelli N, Vigo L, Gorini A, Bonomi A, Veglia F, Tremoli E. Uptake and effectiveness of a primary cardiovascular prevention program in an underserved multiethnic urban community. Nutr Metab Cardiovasc Dis. 2022 May;32(5):1110-1120. doi: 10.1016/j.numecd.2022.01.013. Epub 2022 Jan 16.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Prevention
Not yet recruitingPhase 3
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Enrolling by invitationPhase 3
Quanduzhong Capsules for Primary Osteoporosis
Primary Osteoporosis
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
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.
José Pablo P Werba, MD principal investigator
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening and prevention of CVD in people with Primary Prevention, run by Centro Cardiologico Monzino at 1 site in Italy.
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 2 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 26 Apr 2017. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary adherence at baseline screening (time frame: Baseline). 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 NCT03129165, 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 26 Apr 2017.