NCT03129165

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

March 30, 2017

Last Update Submit

April 21, 2017

Conditions

Primary Prevention

Keywords

Cardiovascular diseasesPublic HealthHypertensionSmokingHypercholesterolemiaFood HabitsExerciseAnxietyDepressionObesityDiabetes

Outcome Measures

Primary Outcomes (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

    Baseline

Secondary Outcomes (22)

  • Influence of education level on primary adherence

    Baseline

  • Influence of working category on primary adherence

    Baseline

  • Influence of immigrant or native status on primary adherence

    Baseline

  • Awareness of own cardiovascular risk factors

    Baseline

  • Accuracy of the perception of own cardiovascular risk

    Baseline

  • +17 more secondary outcomes

Study Arms (1)

Screening and prevention of CVD

EXPERIMENTAL
Other: Screening and prevention of CVD

Interventions

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.

Screening and prevention of CVD

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Live in Milan at neighborhood of Ponte Lambro

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35260313DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionSmokingHypercholesterolemiaFeeding BehaviorMotor ActivityAnxiety DisordersDepressionObesityDiabetes Mellitus

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Vascular DiseasesBehaviorHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior, AnimalMental DisordersBehavioral SymptomsOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • José Pablo P Werba, MD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Unit of Atherosclerosis Prevention, Principal Investigator, Specialist in Internal Medicine

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 26, 2017

Study Start

May 11, 2015

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

IT(1)