Primary Prevention
Conditions
Keywords
Cardiovascular diseases, Public Health, Hypertension, Smoking, Hypercholesterolemia, Food Habits, Exercise, Anxiety, Depression, Obesity, Diabetes
Brief 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.
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.
Interventions
OTHERScreening and prevention of CVD
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.
Sponsors
Centro Cardiologico Monzino
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary adherence at baseline screening | Baseline | Primary adherence evaluated as the ratio between the number of subjects enrolled and the number of subjects actively contacted through personal postal mail |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of education level on primary adherence | Baseline | Assessed as rate of primary adherence according to educational level (years of schooling \<8, 8-12 or \>12) |
| Influence of working category on primary adherence | Baseline | Assessed as rate of primary adherence according to working category (manual worker, service worker, office worker, unemployed, retired) |
| Influence of immigrant or native status on primary adherence | Baseline | Assessed as rate of primary adherence according to immigrant (from any country) or native status |
| Awareness of own cardiovascular risk factors | Baseline | 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 |
| Accuracy of the perception of own cardiovascular risk | Baseline | 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) |
| Prevalence of positive screening for anxiety | Baseline | Anxiety assessed using General Anxiety Disorder 2 (GAD-2) test and defined as positive with a score ≥3 |
| Prevalence of positive screening for depression | Baseline | Depressive mood assessed using Patient Health Questionnaire 2 (PHQ-2) test and defined as positive with a score ≥3 |
| Extent of adherence to the Mediterranean Diet (MD) | Baseline | 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) |
| Prevalence of physically active subjects | Baseline | Physical activity (PA) assessed using the PASSI questionnaire and physically active subjects defined according to the WHO 2010 Guidelines |
| Human resources utilization | Baseline | Percent of enrolled subjects allocated to medical visit, interview with nutritionist, motivational interview to promote physical activity, smoking-cessation program, interview with psychologist |
| Change in positive screening for anxiety | 6 months | Assessed as the net improvement in screening for anxiety (number of positive who became negative minus number of negative who became positive) |
| Changes in adherence to MD at 6 months | 6 months | Assessed as the net improvement in category of adherence to MD (number of those who increased minus number of those who decreased) |
| Changes in PA at 6 months | 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) |
| Changes in declared cigarette consumption | 6 months | 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) |
| Changes in objective measures of cigarette smoke exposure | 6 months | 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) |
| Change in positive screening for depression | 6 months | Assessed as the net improvement in screening for depression (number of positive who became negative minus number of negative who became positive) |
| Global change in traditional risk factors at 6th months | 6 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 |
| Global change in estimated risk at 6th months | 6 months | Assessed as net improvement in Framingham Risk Score (number of subjects who reduced the score minus number of subjects who increased the score) |
| Persistence in the program at 12th months | 12 months | Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled |
| Global change in traditional risk factors at 12th months | 12 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 |
| Global change in estimated risk at 12th months | 12 months | Assessed as net improvement in Framingham Risk Score (number of subjects who reduced the score minus number of subjects who increased the score) |
| Persistence in the program at 6th months | 6 months | Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled |
Countries
Italy
Outcome results
None listed