ENRICHD

恩瑞克

• 批准号: 2357862
• 负责人: JAMES M RACZYNSKI
• 金额: $ 57.51万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/2357862
• 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 对心脏病相关发病率的心理社会干预， 处于高心理社会风险的MI患者的死亡率。 高心理社会 风险被定义为存在抑郁和/或社会孤立。 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， 教育控制组和标准医疗护理组，使用组合 CHD死亡+再梗死终点。 次要终点包括健康- 相关的生活质量;坚持服药和促进健康 行为和缺血性事件，通过动态心电图测量 （AECG）和运动耐量试验（ETT）。 为了实现其目标，该计划建议招募 大约8个临床单位，用于患者登记、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 指导委员会以及数据和安全性监查委员会会议。 预计共有3,000名患者，或约375名 应按临床单位招募患者。 为了确保 研究将提供关于妇女和不同种族/族裔的有意义的数据 总体目标是招聘50%的妇女和50%的少数民族。 妇女和少数民族患者的人数可能因诊所而异 根据当地人口组成和其他特点， 影响获得护理。