Improving Symptoms and Quality of Life in Advanced Chronic Heart Failure

描述(由申请人提供)：改善晚期慢性心力衰竭的症状和生活质量慢性心力衰竭(HF)患者患有许多症状，如呼吸困难、疲劳和疼痛，这些症状会恶化生活质量。先前的姑息性症状管理干预通常不能成功改善心力衰竭患者的症状。我们的初步研究表明，提供心理社会护理的重要性和可行性，以应对加剧其他症状的抑郁症，并将姑息治疗更早地整合到正在进行的心衰护理中。将这些成分添加到姑息性症状管理中提供了一种潜在的成功策略，可以降低症状严重程度和抑郁，从而提高心力衰竭患者的生活质量。这项研究是改善晚期心力衰竭患者症状和生活质量的长期目标的组成部分。这项建议的具体目的是：(1)评估姑息性症状管理和心理社会护理干预对症状严重程度和抑郁的影响作为主要终点，将症状苦恼、疾病适应、自我护理和精神健康作为预先指定的次要终点；(2)评估干预是否通过对症状严重程度和抑郁的影响间接影响生活质量。一项有312名患者参加的三点两臂随机对照临床试验将在一个地理区域进行。在基线、3个月、6个月和12个月时收集症状严重程度、抑郁、疾病适应、自我护理、精神健康和生活质量的测量结果。假说将使用混合效应和结构方程模型进行检验。总的来说，拟议的研究将通过测试一种创新的、基于证据的、理论驱动的姑息症状管理和心理社会护理干预措施，并告知继续开发有针对性的干预措施来改善结果，从而影响对心力衰竭患者的临床护理。干预措施的核心组成部分是为了便于复制、实施和传播，我们计划进行后续研究，对干预措施进行经济分析，并确定干预措施是否对卫生保健利用和生存有影响。这项研究将有助于 在心力衰竭和姑息治疗研究方面的关键差距，并与RFA-NR-11-006的目标直接相关。

DESCRIPTION (provided by applicant): Improving Symptoms and Quality of Life in Advanced Chronic Heart Failure Chronic heart failure (HF) patients suffer from numerous symptoms such as breathlessness, fatigue, and pain that worsen quality of life. Prior palliative symptom management interventions have generally not succeeded in improving symptoms in HF patients. Our preliminary studies show the importance and feasibility of providing psychosocial care to address the depression that intensifies other symptoms and integrating palliative care earlier into ongoing HF care. Adding these components to palliative symptom management offers a potentially successful strategy to reduce symptom severity and depression and thus improve quality of life in HF patients. This research is an integral part of a long term goal to improve symptoms and thus quality of life in patients with advanced HF. The specific aims of this proposal are to: (1) Assess the effect of a palliative symptom management and psychosocial care intervention on symptom severity and depression as primary endpoints, and symptom distress, adjustment to illness, self-care, and spiritual well-being as pre-specified secondary endpoints; (2) Evaluate whether the intervention influences quality of life indirectly through effects on symptom severity and depression. A 3-site, 2-arm randomized, controlled, clinical trial of 312 patients will be conducted in a single geographic region. Measures of symptom severity, depression, adjustment to illness, self-care, spiritual well-being, and quality o life will be collected at baseline, 3, 6, and 12 months. Hypotheses will be tested using mixed effects and structural equation models. Collectively, the proposed studies will impact clinical care for patients with HF by testing an innovative, evidence-based, theory-driven palliative symptom management and psychosocial care intervention and informing continued development of targeted interventions to improve outcomes. The core components of the intervention are structured to ease replication, implementation, and dissemination, and we plan subsequent studies to conduct an economic analysis of the intervention and to determine if the intervention has an effect on health care utilization and survival. This study will contribute to a key gap in HF and palliative care research and is directly linked to the goals of RFA-NR-11-006.