ENRICHD

这项多中心试验的主要目标是评估 心理干预对心脏相关疾病发病率的影响 和高心理社会风险的MI患者的死亡率。高度的心理社会 风险被定义为抑郁和/或社会孤立的存在。 研究设计将比较心理社会干预组，其中 为患者提供社会支持和心理治疗 旨在减少社会孤立和抑郁，具有健康的 教育控制和标准医疗保健小组，使用组合 冠心病死亡+再梗塞的终点。次要终端包括健康- 相关的生活质量；坚持用药和促进健康 通过动态心电图仪测量的行为和缺血事件 (AEC(3)和运动耐量试验(ETT)。 为了实现其目标，该计划建议招募 大约八个临床单元，用于患者接诊、干预、 和数据收集，以及临床协调中心 协调所有数据收集、数据存储、分析活动、 回顾研究的医学进展，并为组织 指导委员会以及数据和安全监测委员会会议。 预计总共有3000名患者，约375人 患者应按临床单位登记。为了确保 研究将提供有关妇女和不同种族/民族的有意义的数据 在这些群体中，总体目标将是招募50%的妇女和50%的少数族裔。 女性和少数族裔患者的数量可能会因诊所而异 诊所取决于当地人口构成和其他 影响获得护理机会的特征。

The primary objective of this multicenter trial is to evaluate the effects of psychosociaI interventions on the cardiac-related morbidity and mortality of MI patients at high psychosocial risk. High psychosocial risk is defined as the presence of depression and/or social isolation. The study design will compare a psychosocial intervention group, in which patients are provided with social support and psychological treatment designed to decrease social isolation and depression, with a health education control and a standard medical care group, using a combined endpoint of CHD death + reinfarction. Secondary endpoints include health- related quality of life; adherence to medications and health-promoting behaviors; and ischemic events, measured by ambulatory electrocardiogram (AEC(3) and exercise tolerance testing (ETT). To accomplish its objective, this program proposes to recruit approximately eight Clinical Units for patient accession, intervention, and data collection, as well as a Clinical Coordinating Center for coordinating all data collection, storage of data, analysis activities, reviewing the medical progress of the study, and for organizing the Steering Committee and the Data and Safety Monitoring Board meetings. It is anticipated that a total of 3,000 patients, or approximately 375 patients shall be enrolled per Clinical Unit. In order to assure that the study will provide meaningful data on women and diverse racial/ethnic groups, the overall goal will be to recruit 50% women and 50% minorities. The numbers of women and -minority patients may vary from clinic to clinic depending on local population composition and other characteristics that influence access to care.