Effectiveness of a Family Heart Health Intervention

描述(申请人提供)：由于共同的基因和生活方式，冠心病(CHD)患者的家庭成员发生血管事件的风险增加。冠心病住院可能代表着家庭成员确定自己的风险并采取行动降低风险的“激励时刻”。我们之前对1500多名住院冠心病患者的家人/朋友进行了筛查，发现近40%的人有患冠心病的3个主要危险因素，只有约10%的人没有。在一项初步研究中，我们发现，教育参与者的短暂干预在3个月后导致生活习惯的显著改善。这项研究的目的是测试家庭护照到心脏健康计划的有效性，这是一项医院外展筛查和教育计划，旨在识别高危人群，提高对心脏健康生活方式的依从性，并在1年内改善心血管疾病的危险因素。本研究设计为随机对照临床试验。受试者将被分配到对照组(N=250)或特别干预(SI)组(N=250)，前者接受有关CHD的一般健康信息，后者接受标准化的CHD风险因素筛查、个性化教育、医院工作人员定期联系，并将结果通知给初级医生。参与者将包括说英语或西班牙语的人，探望纽约长老会医院因急性冠脉综合征或血管重建手术入院的家人/朋友。干预由训练有素的健康教育者/营养师提供，并由一名医生监督。主要结果是SI组与对照组相比，低密度脂蛋白(LDL)胆固醇从基线到1年的平均下降百分比。次要结果包括在1年后达到国家胆固醇教育计划成人治疗小组III定义的治疗生活方式改变饮食，其他脂蛋白、血压、体重指数、腰围、Framingham风险评分和高敏C反应蛋白(HsCRP)的平均百分比变化。将计算降低低密度脂蛋白水平的干预措施的成本效益，以及从降脂治疗的临床结果试验中预计节省的每生命年成本。将评估除传统危险因素外有关hsCRP的信息对实现预防目标的影响。这项研究将提供关于一项新计划的有效性的重要信息，该计划旨在识别冠心病风险人群，并提高2010年健康人目标的实现。

DESCRIPTION (provided by applicant): Family members of individuals with coronary heart disease (CHD) are at increased risk of vascular events due to shared genes and lifestyle. Hospitalization for CHD may represent a "motivational moment" for family members to determine their own risk and take action to lower it. We have previously screened over 1500 family members/friends of patients hospitalized with CHD and found that nearly 40 percent had > 3 major risk factors for CHD and only about 10 percent had none. In a pilot study, we showed that a brief intervention to educate participants resulted in significant improvements in lifestyle habits after 3 months. The purpose of this study is to test the effectiveness of the Family Passport To Heart Health Program, a hospital outreach screening and educational program, to identify persons at risk, increase adherence to heart healthy lifestyles, and improve CVD risk factors at 1 year. The design of the study is a randomized controlled clinical trial. Subjects will be assigned to either a control group that receives general health messages about CHD (N = 250) or a special intervention (SI) group (N=250) that receives standardized CHD risk factor screening, personalized education, regular contact by hospital staff, and notification of results to primary physician. Participants will include English or Spanish speaking individuals visiting family members/friends admitted to New York-Presbyterian Hospital with an acute coronary syndrome or revascularization procedure. The intervention is delivered by trained health educators/dieticians and overseen by a physician. The primary outcome is the mean percent reduction in low density lipoprotein (LDL) cholesterol from baseline to 1 year in the SI vs. control group. Secondary outcomes include attainment of the Therapeutic Lifestyle Change Diet at 1 year as defined by the National Cholesterol Education Program Adult Treatment Panel III, the mean percent change in other lipoproteins, blood pressure, body mass index, waist circumference, Framingham risk score, and high sensitivity C reactive protein (hsCRP). Cost-effectiveness of the intervention to reduce LDL levels will be calculated as well as cost per life year saved projected from clinical outcome trials of lipid lowering therapy. The impact of information about hsCRP beyond traditional risk factors on attainment of prevention goals will be assessed. This study will provide important information about the effectiveness of a novel program to identify persons at risk of CHD and increase attainment of Healthy People 2010 Objectives.