Quality of Life Therapy for Adults with ESRD Awaiting Renal Transplantation

等待肾移植的终末期肾病成人的生活质量治疗

• 批准号: 7216605
• 负责人: James R Rodrigue
• 金额: $ 21.25万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7216605
• 关键词: audiotape; behavior test; behavioral /social science research tag; caregivers; chronic renal failure; clinical research; clinical trials; health disparity; human subject; human therapy evaluation; interpersonal relations; interview; isolation /deprivation; kidney transplantation; longitudinal human study; medical records; patient oriented research; psychotherapy; quality of life; racial /ethnic difference; therapy compliance

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.

描述（由申请人提供）：项目总结：尽管已知终末期肾病（ESRD）相关的生活质量（QOL）缺陷，但很少尝试制定策略来改善等待肾移植的ESRD成人患者的生活质量。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机制，确定哪些患者从生活质量干预中获益最多，并确定生活质量的益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治疗（QOLT）在治疗等待肾移植的成人ESRD患者中的有效性、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患者的生活质量，心理功能和社会亲密度。本申请旨在研究这种干预是否可以有效地适应和实施与成人，终末期肾病谁是等待肾移植。中心假设是，通过针对特定生活领域的改善，QOLT在QOL、心理功能和患者-护理者关系方面产生显著的临床益处。将通过追求三个具体目标来检验这一假设：1）确定QOLT的有效性; 2）按种族（白色、非裔美国人）检查QOLT的差异有效性; 3）评估多中心R 01应用的可行性。在第一个目标下，等待肾移植的ESRD成人患者将随机接受QOLT、支持治疗（ST）或标准治疗（SC）。主要结果将是治疗后1周和12周的QOL，心理功能和社交亲密度的变化。在第二个目标下，将仔细研究种族与干预结果之间的关系。在第三个目标下，将收集流失率、流失原因、治疗师对治疗方案的依从性和受试者满意度评级，以评估在开发更大规模的多中心临床试验R 01申请之前是否需要进行方案变更。这项研究是创新的，因为它是第一个评估理论驱动的心理干预，以专门改善生活质量的ESRD和肾移植的背景下。这项拟议的研究意义重大，因为它有望推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：这是一个重要的、研究不足的领域.由于肾移植的等待时间很长，以及透析相关的负担，有效的生活质量干预措施可用于改善所有因其他原因残疾并等待移植的患者的福祉质量。这些益处有可能延长单纯移植的QOL结局。