Coping Skills Training in Heart Failure: Outcomes and Mechanisms

描述(由申请人提供)：心力衰竭的应对技能培训：结果和机制。超过500万美国人患有心力衰竭(HF)，每年相关的医疗费用超过330亿美元。随着每年新增500,000例病例，心力衰竭是发病率唯一上升的主要心血管疾病。尽管进行了密集的药物治疗，但症状不稳定和临床恶化是常见的，并导致频繁的医生就诊、住院，最终导致死亡。心力衰竭症状，包括呼吸困难和疲劳，是心力衰竭患者痛苦的主要来源，并经常对他们的日常活动施加严重限制。抑郁症在心力衰竭患者中也很常见，它的存在与住院和死亡率的增加有关，与疾病的严重程度无关。越来越多的证据表明，行为管理是与HF生活在一起的关键组成部分，可以减少住院次数，帮助优化健康状况。尽管先前的研究已经证明，病例管理计划是有效的，但一旦减少持续护理，好处似乎是短暂的。我们实验室和其他机构先前的研究表明，应对技能培训(CST)对糖尿病、缺血性心脏病和肺部疾病等慢性病有效。CST旨在教授患者自我管理技能，并更有效地应对与其疾病相关的心理困扰。然而，CST尚未被评估为促进心力衰竭自我管理的干预措施。我们提出了一项随机临床试验，比较了16周的CST干预和延长(标准化)护理在200名心力衰竭门诊患者中的研究样本，根据当前的临床实践指南，这些患者正在接受心力衰竭的治疗。通过电话提供的CST干预旨在减少压力和抑郁，并改善与心力衰竭结果相关的健康行为方面，包括症状监测、用药依从性、饮食依从性和体力活动。在治疗前后，患者将仔细评估重要的中间医学终点，包括心力衰竭的生物标志物(B型利钠肽、射血分数、血管内皮功能、自主神经调节和炎症活动)，以及身体和心理社会功能指示的生活质量(QOL)。CST对临床结果的影响将根据所有原因的住院或死亡率在中位数3年的随访期内进行评估。这项拟议的研究产生的数据将提供关于CST的价值高于常规医疗的重要见解。如果成功，我们认为研究结果将转化为将CST纳入自我管理行为干预的初步建议，作为提高心力衰竭患者疾病管理、生活质量和寿命的经济有效的方法。与公共健康相关：心力衰竭是一种心脏失去有效泵血能力的疾病，影响着500多万美国人，每年新增诊断病例50万例。心力衰竭限制了生活的质量和数量，是美国住院的头号原因，相关的年度医疗费用超过330亿美元。我们建议的临床试验旨在评估应对技能干预，旨在增强心力衰竭患者的健康相关行为，减少心理困扰，从而改善健康状况，提高生活质量，降低医疗成本。

DESCRIPTION (provided by applicant): Coping Skills Training in Heart Failure: Outcomes and Mechanisms. Over 5 million Americans suffer from heart failure (HF), with an associated annual health care cost in excess of $33 billion. With 500,000 new cases developing each year, HF is the only major cardiovascular disease that is increasing in prevalence. Despite intensive medical therapy, symptom instability and clinical deterioration are common and lead to frequent physician visits, hospitalization, and ultimately death. HF symptoms, including dyspnea and fatigue, are a major source of distress for patients with HF, and often impose severe limitations on their daily activities. Depression also is common in HF patients, and its presence is associated with increased risk of hospitalization and mortality, independent of disease severity. There is growing evidence that behavioral management is a critical component of living with HF that can reduce hospitalizations and help optimize health status. Although previous studies have demonstrated that case- management programs are effective, benefits appear to be short-lived once ongoing care is reduced. Prior research from our laboratory and others has shown that coping skills training (CST), designed both to teach patients self-management skills and to cope more effectively with psychological distress associated with their medical condition, is effective for such chronic diseases as diabetes, ischemic heart disease, and lung disease. However, CST has not yet been evaluated as an intervention to facilitate self-management of HF. We propose a randomized clinical trial comparing a 16-week CST intervention with Extended (Standardized) Care in a study sample of 200 HF outpatients, who are receiving medical treatment for HF according to current clinical practice guidelines. The CST intervention, delivered over the telephone, is designed reduce stress and depression and to improve aspects of health behavior that are related to HF outcomes, including symptom monitoring, medication adherence, dietary compliance, and physical activity. Before and following treatment, patients will be carefully assessed on important intermediate medical endpoints including HF disease biomarkers (B-type natriuretic peptide, ejection fraction, vascular endothelial function, autonomic regulation, and inflammatory activity), as well as on quality of life (QoL) indicated by both physical and psychosocial functioning. Effects of CST on clinical outcomes will be evaluated according to all-cause hospitalizations or mortality over a median follow-up period of 3 years. The data generated by the proposed study will provide important insights regarding the value of CST over and above usual medical care. If successful, we believe that the study findings should translate into initial recommendations for the incorporation of CST into self- management behavioral interventions as cost-effective approaches to enhance disease management, QoL and longevity in HF patients. PUBLIC HEALTH RELEVANCE: Heart failure, a disorder in which the heart loses its ability to pump blood effectively, affects over five million Americans, with 500,000 new cases being diagnosed each year. Heart failure restricts both quality and quantity of life, and is the number one reason for hospitalization in the United States, with an associated annual health care cost exceeding $33 billion. Our proposed clinical trial is designed to evaluate a Coping Skills Intervention designed to enhance health-related behaviors and reduce psychological distress in heart failure patients, resulting in improved health status, better quality of life and lowered health care costs.