ProSALUTE: Community Program for Cardiovascular Health (ProSALUTE)

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.

Study Overview

• Status: Unknown
• Conditions: Primary Prevention
• Intervention / Treatment: Other: Screening and prevention of CVD

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2015
• Primary Completion (Anticipated): May 11, 2018
• Study Completion (Anticipated): May 11, 2018

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 21, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Exercise; Obesity; Hypertension; Anxiety; Smoking; Hypercholesterolemia; Cardiovascular diseases; Public Health; Food Habits
• Other Study ID Numbers: R212/15 - CCM 226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No