Quality of Life Therapy for Adults with ESRD Awaiting Renal Transplantation

描述(由申请人提供)：项目摘要：尽管已知与终末期肾病(ESRD)相关的生活质量(QOL)缺陷，但很少有人尝试制定策略来改善等待肾移植的ESRD成人的QOL。这项研究计划的长期目标是更好地了解如何提高生活质量，确定生活质量变化的潜在机制，确定哪些患者从生活质量干预中受益最大，并确定生活质量的好处是否可以延伸到移植之外。本申请的目的是确定生活质量疗法(QOLT)在治疗成人终末期肾病等待肾移植中的有效性、可行性和适用性。在最近的一项小型、单中心临床试验中，我们证明了QOLT可以改善等待肺移植的患者的生活质量、心理功能和社会亲密度。这项申请旨在检查这种干预措施是否可以有效地适应和实施于正在等待肾移植的患有终末期肾病的成年人。中心假设是，通过针对特定生活领域的改善，QOLT在生活质量、心理功能和患者-照顾者关系方面产生了显著的临床益处。这一假设将通过追求三个具体目标来检验：1)确定QOLT的有效性；2)按种族(白人、非裔美国人)检验QOLT的差异有效性；以及3)评估多地点R01应用的可行性。在第一个目标下，等待肾移植的ESRD成人将随机接受QOLT、支持性治疗(ST)或标准护理(SC)。主要结果是治疗后1周和12周生活质量、心理功能和社交亲密度的变化。在第二个目标下，将密切研究种族和干预结果之间的关系。在第三个目标下，将收集流失率、减员原因、治疗师对治疗方案的遵守情况和参与者满意度评分，以评估在开发更大的多站点临床试验R01应用程序之前是否需要更改方案。这项研究具有创新性，因为它是第一个评估在终末期肾病和肾移植的背景下，通过理论驱动的心理干预来具体改善生活质量的研究之一。这项拟议的研究具有重要意义，因为它有望促进和扩大对如何改善终末期肾病患者生活质量的理解。与公共卫生的相关性：这是一个重要但调查不足的领域。由于肾移植的等待时间非常长，以及与透析相关的负担，可以使用有效的生活质量干预措施来改善所有因其他原因致残并等待移植的患者的生活质量。这些好处有可能延长单独移植带来的生活质量结果。

DESCRIPTION (provided by applicant): Project Summary: Despite known quality of life (QOL) deficits associated with end-stage renal disease (ESRD), there have been very few attempts to develop strategies to improve QOL in adults with ESRD awaiting renal transplantation. The long-term goal of this research program is to better understand how QOL can be enhanced, to identify the mechanisms underlying QOL changes, to identify which patients benefit most from QOL intervention, and to determine whether QOL benefits can extend beyond transplantation. The objective of this application is to determine the effectiveness, feasibility and applicability of Quality of Life Therapy (QOLT) in treating adults with ESRD awaiting renal transplantation. In a recent small, single-center clinical trial, we demonstrated that QOLT can improve QOL, psychological functioning, and social intimacy in patients awaiting lung transplantation. This application seeks to examine whether this intervention can be effectively adapted and implemented with adults with ,ESRD who are awaiting renal transplantation. The central hypothesis is that by targeting improvements in specific life domains, QOLT yields significant clinical benefits in QOL, psychological functioning, and the patient-caregiver relationship. This hypothesis will be tested by pursuing three specific aims: 1) Determine the effectiveness of QOLT; 2) Examine the differential effectiveness of QOLT by race (White, African American); and 3) Assess the feasibility of a multisite R01 application. Under the first aim, adults with ESRD awaiting renal transplantation will be randomized to receive QOLT, Supportive Therapy (ST), or Standard Care (SC). Primary outcomes will be changes in QOL, psychological functioning, and social intimacy at 1 and 12 weeks post-treatment. Under the second aim, the relationship between race and intervention outcomes will be closely examined. Under the third aim, attrition rates, reasons for attrition, therapist adherence to treatment protocols, and participant satisfaction ratings will be gathered to assess the need for protocol changes prior to developing a larger, multisite clinical trial R01 application. This study is innovative because it is among the first to evaluate a theoretically-driven psychological intervention to specifically improve QOL in the context of ESRD and renal transplantation. The proposed research is significant because it is expected to advance and expand understanding of how QOL can be improved in patients with ESRD. Relevance to Public Health: This is an important and under- investigated area. With very long waiting times to renal transplantation and the burdens associated with dialysis, effective QOL interventions can be used to improve the quality of well-being for all patients who are otherwise medically disabled and awaiting transplantation. These benefits have the potential to extend the QOL outcomes otherwise derived from transplantation alone.