ProSALUTE: Community Program for Cardiovascular Health (ProSALUTE)

• ClinicalTrials.gov Identifier: NCT03129165
• Recruitment Status: Unknown
• First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Sponsor: Centro Cardiologico Monzino
• Information provided by (Responsible Party): José Pablo Werba, Centro Cardiologico Monzino

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Prevention	Other: Screening and prevention of CVD	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: ProSALUTE: a New Community Program for Cardiovascular Health
• Actual Study Start Date: May 11, 2015
• Estimated Primary Completion Date: May 11, 2018
• Estimated Study Completion Date: May 11, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Screening and prevention of CVD	Other: Screening 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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Influence of education level on primary adherence [ Time Frame: Baseline ]
   Assessed as rate of primary adherence according to educational level (years of schooling <8, 8-12 or >12)
2. Influence of working category on primary adherence [ Time Frame: Baseline ]
   Assessed as rate of primary adherence according to working category (manual worker, service worker, office worker, unemployed, retired)
3. Influence of immigrant or native status on primary adherence [ Time Frame: Baseline ]
   Assessed as rate of primary adherence according to immigrant (from any country) or native status
4. Awareness of own cardiovascular risk factors [ Time Frame: 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
5. Accuracy of the perception of own cardiovascular risk [ Time Frame: 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)
6. Prevalence of positive screening for anxiety [ Time Frame: Baseline ]
   Anxiety assessed using General Anxiety Disorder 2 (GAD-2) test and defined as positive with a score ≥3
7. Prevalence of positive screening for depression [ Time Frame: Baseline ]
   Depressive mood assessed using Patient Health Questionnaire 2 (PHQ-2) test and defined as positive with a score ≥3
8. Extent of adherence to the Mediterranean Diet (MD) [ Time Frame: 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)
9. Prevalence of physically active subjects [ Time Frame: Baseline ]
   Physical activity (PA) assessed using the PASSI questionnaire and physically active subjects defined according to the WHO 2010 Guidelines
10. Human resources utilization [ Time Frame: Baseline ]
    Percent of enrolled subjects allocated to medical visit, interview with nutritionist, motivational interview to promote physical activity, smoking-cessation program, interview with psychologist
11. Persistence in the program at 6th months [ Time Frame: 6 months ]
    Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled
12. Changes in adherence to MD at 6 months [ Time Frame: 6 months ]
    Assessed as the net improvement in category of adherence to MD (number of those who increased minus number of those who decreased)
13. Changes in PA at 6 months [ Time Frame: 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)
14. Changes in declared cigarette consumption [ Time Frame: 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)
15. Changes in objective measures of cigarette smoke exposure [ Time Frame: 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)
16. Change in positive screening for anxiety [ Time Frame: 6 months ]
    Assessed as the net improvement in screening for anxiety (number of positive who became negative minus number of negative who became positive)
17. Change in positive screening for depression [ Time Frame: 6 months ]
    Assessed as the net improvement in screening for depression (number of positive who became negative minus number of negative who became positive)
18. Global change in traditional risk factors at 6th months [ Time Frame: 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
19. Global change in estimated risk at 6th months [ Time Frame: 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)
20. Persistence in the program at 12th months [ Time Frame: 12 months ]
    Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled
21. Global change in traditional risk factors at 12th months [ Time Frame: 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
22. Global change in estimated risk at 12th months [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

Centro Cardiologico Monzino

Milan, Italy, 20138

Sponsors and Collaborators

Centro Cardiologico Monzino

Investigators

• Principal Investigator: José Pablo P Werba, MD; Centro Cardiologico Monzino

More Information

• Responsible Party: José Pablo Werba, Head of Unit of Atherosclerosis Prevention, Principal Investigator, Specialist in Internal Medicine, Centro Cardiologico Monzino
• ClinicalTrials.gov Identifier: NCT03129165
• Other Study ID Numbers: R212/15 - CCM 226
• First Posted: April 26, 2017
• Last Update Posted: April 26, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by José Pablo Werba, Centro Cardiologico Monzino:

Cardiovascular diseases; Public Health; Hypertension; Smoking; Hypercholesterolemia; Food Habits; Exercise; Anxiety; Depression; Obesity; Diabetes