Clinical trial NCT03129165: ProSALUTE: Community Program for Cardiovascular Health
Official title: ProSALUTE: a New Community Program for Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Prevention
Keywords: Cardiovascular diseases
Public Health
Hypertension
Smoking
Hypercholesterolemia
Food Habits
Exercise
Anxiety
Depression
Obesity
Diabetes
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Primary adherence at baseline screening
timeFrame: Baseline
Secondary outcomes:
measure: Influence of education level on primary adherence
timeFrame: Baseline
measure: Influence of working category on primary adherence
timeFrame: Baseline
measure: Influence of immigrant or native status on primary adherence
timeFrame: Baseline
measure: Awareness of own cardiovascular risk factors
timeFrame: Baseline
measure: Accuracy of the perception of own cardiovascular risk
timeFrame: Baseline
measure: Prevalence of positive screening for anxiety
timeFrame: Baseline
measure: Prevalence of positive screening for depression
timeFrame: Baseline
measure: Extent of adherence to the Mediterranean Diet (MD)
timeFrame: Baseline
measure: Prevalence of physically active subjects
timeFrame: Baseline
measure: Human resources utilization
timeFrame: Baseline
measure: Persistence in the program at 6th months
timeFrame: 6 months
measure: Changes in adherence to MD at 6 months
timeFrame: 6 months
measure: Changes in PA at 6 months
timeFrame: 6 months
measure: Changes in declared cigarette consumption
timeFrame: 6 months
measure: Changes in objective measures of cigarette smoke exposure
timeFrame: 6 months
measure: Change in positive screening for anxiety
timeFrame: 6 months
measure: Change in positive screening for depression
timeFrame: 6 months
measure: Global change in traditional risk factors at 6th months
timeFrame: 6 months
measure: Global change in estimated risk at 6th months
timeFrame: 6 months
measure: Persistence in the program at 12th months
timeFrame: 12 months
measure: Global change in traditional risk factors at 12th months
timeFrame: 12 months
measure: Global change in estimated risk at 12th months
timeFrame: 12 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Centro Cardiologico Monzino
name: José Pablo P Werba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.