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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening and prevention of CVD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening and prevention of CVD | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Influence of working category on primary adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Pablo P Werba, MD | Centro Cardiologico Monzino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35260313 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D012907 | Smoking |
| D006937 | Hypercholesterolemia |
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D001519 | Behavior |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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|
Assessed as rate of primary adherence according to working category (manual worker, service worker, office worker, unemployed, retired)
| 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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 | Baseline |
| Persistence in the program at 6th months | Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 6 months |
| Persistence in the program at 12th months | Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled | 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 | 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) | 12 months |
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001522 | Behavior, Animal |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |