ProSALUTE: Community Program for Cardiovascular Health

Primary Prevention Clinical Trial

— ProSALUTE  

Official title:

ProSALUTE: a New Community Program for Cardiovascular Health

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03129165
• Other study ID #: R212/15 - CCM 226
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 30, 2017
• Last updated: April 21, 2017
• Start date: May 11, 2015
• Est. completion date: May 11, 2018

Study information

• Verified date: April 2017
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Prevention

Intervention

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.

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Persistence in the program at 6th months	Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Persistence in the program at 12th months	Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled	12 months
Secondary	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
Secondary	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

External Links

•   Go here for more information about this study: www.prosalute.org