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Primary PreventionProSALUTENCT03129165

ProSALUTE: Community Program for Cardiovascular Health

A study testing Screening and prevention of CVD in people with Primary Prevention, run by Centro Cardiologico Monzino at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Primary Prevention
What is being tested?
Screening and prevention of CVD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteItaly
Study dates
11 May 2015to 11 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Live in Milan at neighborhood of Ponte Lambro

Who cannot join

  • Patients with known atherosclerotic disease (secondary prevention)
  • Severe diseases or disabilities that hinder the participation in the program

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Centro Cardiologico Monzino

    Milan, 20138

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Screening and prevention of CVD
Keywords
Cardiovascular diseases, Public Health, Hypertension, Smoking, Hypercholesterolemia, Food Habits, Exercise, Anxiety, Depression, Obesity, Diabetes
Medical subject headings
Cardiovascular Diseases, Hypertension, Smoking, Hypercholesterolemia, Feeding Behavior, Motor Activity, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Screening and prevention of CVDOther

    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.

Study groups in NCT03129165
Study groupRoleWhat they receive
Screening and prevention of CVDExperimentalNot described
Receives: Other: Screening and prevention of CVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline

Secondary outcomes (22)
  1. 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)

    Measured: Baseline

  2. 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)

    Measured: Baseline

  3. Influence of immigrant or native status on primary adherence

    Assessed as rate of primary adherence according to immigrant (from any country) or native status

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. 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)

    Measured: Baseline

  6. Prevalence of positive screening for anxiety

    Anxiety assessed using General Anxiety Disorder 2 (GAD-2) test and defined as positive with a score ≥3

    Measured: Baseline

  7. 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

    Measured: Baseline

  8. 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)

    Measured: Baseline

  9. Prevalence of physically active subjects

    Physical activity (PA) assessed using the PASSI questionnaire and physically active subjects defined according to the WHO 2010 Guidelines

    Measured: Baseline

  10. 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

    Measured: Baseline

  11. Persistence in the program at 6th months

    Persistence assessed as the ratio between subjects followed at 6 months and subjects enrolled

    Measured: 6 months

  12. 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)

    Measured: 6 months

  13. 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)

    Measured: 6 months

  14. 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)

    Measured: 6 months

  15. 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)

    Measured: 6 months

  16. 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)

    Measured: 6 months

  17. 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)

    Measured: 6 months

  18. 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

    Measured: 6 months

  19. 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)

    Measured: 6 months

  20. Persistence in the program at 12th months

    Persistence assessed as the ratio between subjects followed at 12 months and subjects enrolled

    Measured: 12 months

  21. 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

    Measured: 12 months

  22. 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)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2017
  2. Study start11 May 2015
  3. Primary completion11 May 2018 (estimated)
  4. Study completion11 May 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03129165
Sponsor's protocol ID
R212/15 - CCM 226
Acronym
ProSALUTE
Status last verified
Apr 2017
First submitted
30 Mar 2017
Last updated
26 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 35260313

Questions about this trial

What is this clinical trial studying?

A study testing Screening and prevention of CVD in people with Primary Prevention, run by Centro Cardiologico Monzino at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary adherence at baseline screening (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03129165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.

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