ENRICHD

恩瑞克

• 批准号: 2313995
• 负责人: ROBERT Frank DEBUSK
• 金额: $ 19.7万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-29 至 2001-09-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2313995
• 关键词: ENRICHD

The primary objective of this multicenter trial is to evaluate the effects of psychosocial 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 (AECG) 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.

这项多中心试验的主要目的是评估 心理社会干预对心脏相关发病率的影响 以及具有高社会心理风险的 MI 患者的死亡率。高社会心理 风险被定义为抑郁症和/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，并促进健康 教育控制和标准医疗护理组，使用组合 CHD死亡+再梗塞的终点。次要终点包括健康 相关的生活质量；坚持药物治疗和促进健康 行为；和缺血事件，通过动态心电图测量 （AECG）和运动耐量测试（ETT）。 为了实现其目标，该计划建议招募 大约八个临床单位用于患者就诊、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， 审查研究的医学进展，并组织研究 指导委员会以及数据和安全监测委员会会议。 预计共有 3,000 名患者，即约 375 名患者 患者应按临床单位入组。为了确保 研究将提供有关妇女和不同种族/族裔的有意义的数据 团体中，总体目标是招募 50% 的女性和 50% 的少数族裔。 女性和少数族裔患者的数量可能因诊所而异 取决于当地人口构成和其他特征 影响获得护理的机会。