ProSALUTE: a New Community Program for Cardiovascular Health
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
- 否
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
José Pablo Werba
Head of Unit of Atherosclerosis Prevention, Principal Investigator, Specialist in Internal Medicine
Centro Cardiologico Monzino
