跳至主要内容
临床试验/NCT03129165
NCT03129165Unknown不适用

ProSALUTE: a New Community Program for Cardiovascular Health

Centro Cardiologico Monzino2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年5月11日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
Primary adherence at baseline screening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Live in Milan at neighborhood of Ponte Lambro

排除标准

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

结局指标

主要结局

Primary adherence at baseline screening

时间窗: Baseline

Primary adherence evaluated as the ratio between the number of subjects enrolled and the number of subjects actively contacted through personal postal mail

次要结局

  • Influence of immigrant or native status on primary adherence(Baseline)
  • Influence of education level on primary adherence(Baseline)
  • Persistence in the program at 6th months(6 months)
  • Changes in adherence to MD at 6 months(6 months)
  • Changes in objective measures of cigarette smoke exposure(6 months)
  • Global change in traditional risk factors at 6th months(6 months)
  • Global change in estimated risk at 6th months(6 months)
  • Awareness of own cardiovascular risk factors(Baseline)
  • Prevalence of positive screening for anxiety(Baseline)
  • Extent of adherence to the Mediterranean Diet (MD)(Baseline)
  • Prevalence of physically active subjects(Baseline)
  • Change in positive screening for depression(6 months)
  • Persistence in the program at 12th months(12 months)
  • Global change in estimated risk at 12th months(12 months)
  • Influence of working category on primary adherence(Baseline)
  • Prevalence of positive screening for depression(Baseline)
  • Human resources utilization(Baseline)
  • Change in positive screening for anxiety(6 months)
  • Global change in traditional risk factors at 12th months(12 months)
  • Accuracy of the perception of own cardiovascular risk(Baseline)
  • Changes in PA at 6 months(6 months)
  • Changes in declared cigarette consumption(6 months)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Pablo Werba

Head of Unit of Atherosclerosis Prevention, Principal Investigator, Specialist in Internal Medicine

Centro Cardiologico Monzino

研究点 (2)

Loading locations...

相似试验