Coping, Depression and Heart Failure Outcomes

描述（由申请人提供）：拟议的研究和培训计划的长期目标是为K01提案的发展提供基础，该提案使用生物行为干预来探索成人心力衰竭（HF）患者的应对策略、心理困扰和健康结果之间的潜在因果关系。提出的前瞻性描述性研究将使用Lazarus和Folkman的应对过程理论（1984）作为组织框架，但将超越它来检查应对策略，抑郁，交感神经系统激活，炎症细胞因子产生和健康结果之间的关系，这些研究将从范德比尔特心脏研究所招募的成年HF患者（N=150）。应对策略、抑郁症状、发病率（再次住院）和死亡率（心源性死亡）之间的纵向关系将在基线、3个月和6个月三个时间点进行检查。在基线测量后4-6周测量SNS激活和细胞因子产生的生物标志物。影响研究变量随时间变化的因素将使用生长曲线分析和结构方程建模进行检验和建模。相关的培训计划旨在提供高级统计学、临床免疫学和实验室分析方法方面的高级培训。这些课程是通过范德比尔特综合临床研究中心（GCRC）临床研究硕士（MSCI）项目提供的。这个项目是为了培训新的医生和护士临床调查员在以病人为导向的研究中使用的技术和过程。本课程旨在提供直接的临床研究指导经验，并通过教学工作，为学员提供研究设计，生物统计学，生物医学伦理学，临床药理学，人类遗传学，免疫学和分析方法的坚实基础。建议的研究结果将为在资助期的第三年开发R01申请提供基础。

DESCRIPTION (provided by applicant): The long-term objectives for the proposed research and training plans are to provide a basis for the development of a K01 proposal that uses biobehavioral interventions to explore potential causal relationships among coping strategies, psychological distress, and health outcomes in adults with heart failure (HF). The proposed prospective, descriptive study will make use of Lazarus and Folkman's Coping Process Theory (1984) as an organizing framework, but will go beyond it to examine the relationships among coping strategies, depression, sympathetic nervous system activation, inflammatory cytokine production, and health outcomes in a stratified, quota sample of adults (N=150) living with HF who will be recruited from Vanderbilt Heart Institute. The longitudinal relationships among coping strategies, depressive symptoms, morbidity (re-hospitalization), and mortality (cardiac death) will be examined at three time points - baseline, 3, and 6 months. Biomarkers for SNS activation and cytokine production will be measured 4-6 weeks following baseline measures. The factors that influence changes in study variables over time will be examined and modeled using growth curve analyses and structural equation modeling. The associated training plan is designed to provide advanced training in advanced statistics, clinical immunology, and laboratory assay methods. These courses are offered through the Vanderbilt General Clinical Research Center's (GCRC) Master of Science in Clinical Investigation (MSCI) Program. This program was developed in order to train new physician and nurse clinical investigators in the techniques and processes utilized in patient-oriented research. This program is intended to provide direct, mentored experiences in clinical investigation and, through didactic work, to provide trainees with a strong foundation in study design, biostatistics, biomedical ethics, clinical pharmacology, human genetics, immunology, and assay methods. The results of the proposed study will provide a foundation for the development of an R01 application during year 3 of the award period.