Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
J Card Fail. 2011 Mar;17(3):201-7. doi: 10.1016/j.cardfail.2010.11.001. Epub 2011 Jan 21.
Coping Effectively with Heart Failure (COPE-HF) is an ongoing randomized clinical trial funded by the National Institutes of Health to evaluate if a coping skills training (CST) intervention will result in improved health status and quality of life as well as reduced mortality and hospitalizations compared with a heart failure education (HFE) intervention.
Two hundred heart failure (HF) patients recruited from the Duke University Medical Center and the University of North Carolina Hospital system will be randomized to a CST intervention (16 weekly 30-minute telephone counseling sessions including motivational interviewing and individually tailored cognitive behavioral therapy) or to an HFE intervention (16 weekly 30-minute telephone sessions including education and symptom monitoring). Primary outcomes will include postintervention effects on HF biomarkers (B-type natriuretic peptide, ejection fraction) and quality of life, as well as long-term clinical outcomes (hospitalizations and death). Secondary analyses will include an evaluation of treatment effects across subpopulations, and potential mechanisms by which CST may improve clinical outcomes.
COPE-HF is a proof-of-concept study that should provide important insights into the health benefits of a CST intervention designed to enhance HF self-management, improve health behaviors, and reduce psychologic distress.
《有效应对心力衰竭(COPE-HF)》是一项正在进行的由美国国立卫生研究院资助的随机临床试验,旨在评估应对技能培训(CST)干预是否会导致健康状况和生活质量的改善,以及与心力衰竭教育(HFE)干预相比,死亡率和住院率的降低。
从杜克大学医学中心和北卡罗来纳大学医院系统招募的 200 名心力衰竭(HF)患者将被随机分配到 CST 干预组(16 周每周 30 分钟的电话咨询,包括动机访谈和个性化的认知行为疗法)或 HFE 干预组(16 周每周 30 分钟的电话会议,包括教育和症状监测)。主要结局将包括干预后 HF 生物标志物(B 型利钠肽、射血分数)和生活质量的变化,以及长期临床结局(住院和死亡)。次要分析将包括评估 CST 在亚人群中的治疗效果,以及 CST 改善临床结局的潜在机制。
COPE-HF 是一项概念验证研究,应该为 CST 干预对增强 HF 自我管理、改善健康行为和减轻心理困扰的健康益处提供重要的见解。