ProSALUTE: Community Program for Cardiovascular Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ProSALUTE: a New Community Program for Cardiovascular Health

Conditions
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Primary Prevention

Intervention / Treatment
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* Other: Screening and prevention of CVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Live in Milan at neighborhood of Ponte Lambro Exclusion Criteria: Patients with known atherosclerotic disease (secondary prevention) Severe diseases or disabilities that hinder the participation in the program

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening and prevention of CVD<br> | Other: Screening and prevention of CVD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular diseases, Public Health, Hypertension, Smoking, Hypercholesterolemia, Food Habits, Exercise, Anxiety, Depression, Obesity, Diabetes