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，这些症状使生活质量恶化。既往姑息性症状管理干预通常不能成功改善HF患者的症状。我们的初步研究表明，提供心理社会护理，以解决加重其他症状的抑郁症，并将姑息治疗早期纳入正在进行的HF护理的重要性和可行性。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，以减轻症状严重程度和抑郁，从而改善HF患者的生活质量。这项研究是改善晚期HF患者症状和生活质量的长期目标的组成部分。本提案的具体目的是：（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），以及症状困扰、疾病适应、自我护理和精神健康（作为预先规定的次要终点）;（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。将在一个地理区域内对312例患者进行一项3中心、2组、随机、对照临床试验。将在基线、3、6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指标。将使用混合效应和结构方程模型对假设进行检验。总的来说，拟议的研究将通过测试创新的、以证据为基础的、理论驱动的姑息性症状管理和心理社会护理干预来影响HF患者的临床护理，并为持续开发有针对性的干预措施以改善结局提供信息。干预的核心组成部分的结构，以方便复制，实施和传播，我们计划后续的研究进行干预的经济分析，并确定干预措施是否对医疗保健的利用和生存的影响。这项研究将有助于 HF和姑息治疗研究的关键差距，与RFA-NR-11-006的目标直接相关。 公共卫生相关性：慢性心力衰竭是一个重要的公共卫生问题，因为它是残疾、住院、死亡和费用的主要原因。患有晚期慢性心力衰竭的人患有许多影响他们日常生活的症状。我们将进行一项随机临床试验，以评估姑息性症状管理和心理社会护理干预，以减少症状的严重程度和抑郁症。结果将直接关系到患有这种疾病的患者和家庭，以及提供者，付款人和其他研究人员。

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. PUBLIC HEALTH RELEVANCE: Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. We will conduct a randomized clinical trial to evaluate a palliative symptom management and psychosocial care intervention to reduce symptom severity and depression. The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.