Coping Skills Training in Heart Failure: Outcomes and Mechanisms

描述（由申请人提供）：心力衰竭应对技能培训：结果和机制。 超过500万美国人患有心力衰竭（HF），相关的年度医疗保健费用超过330亿美元。每年有50万新发病例，HF是唯一一种患病率正在增加的主要心血管疾病。尽管进行了强化药物治疗，但症状不稳定和临床恶化仍很常见，并导致频繁的医生就诊、住院治疗，最终死亡。HF症状，包括呼吸困难和疲劳，是HF患者痛苦的主要来源，并且经常严重限制他们的日常活动。抑郁在HF患者中也很常见，其存在与住院和死亡风险增加相关，与疾病严重程度无关。越来越多的证据表明，行为管理是HF患者生活的关键组成部分，可以减少住院治疗并帮助优化健康状况。虽然先前的研究已经证明，个案管理计划是有效的，但一旦持续的护理减少，其益处似乎是短暂的。我们实验室和其他人的先前研究表明，应对技能训练（CST），旨在教授患者自我管理技能，并更有效地科普与其医疗状况相关的心理困扰，对糖尿病，缺血性心脏病和肺部疾病等慢性疾病有效。然而，CST尚未被评估为促进HF自我管理的干预措施。我们提出了一项随机临床试验，在200例HF门诊患者的研究样本中比较16周CST干预与扩展（标准化）护理，这些患者根据当前临床实践指南接受HF药物治疗。通过电话进行的CST干预旨在减轻压力和抑郁，并改善与HF结局相关的健康行为方面，包括症状监测、药物依从性、饮食依从性和体力活动。在治疗前后，将仔细评估患者的重要中间医学终点，包括HF疾病生物标志物（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）。将根据中位随访期3年内的全因住院或死亡率评价CST对临床结局的影响。拟议研究产生的数据将提供关于CST超过常规医疗护理的价值的重要见解。如果成功，我们认为研究结果应转化为将CST纳入自我管理行为干预的初步建议，作为提高HF患者疾病管理、QoL和寿命的成本效益方法。公共卫生相关性：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，每年诊断出50万新病例。心力衰竭限制了生活的质量和数量，并且是美国住院的头号原因，相关的年度医疗保健费用超过330亿美元。我们拟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并减少心理困扰，从而改善健康状况，提高生活质量并降低医疗保健成本。

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.