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）：项目摘要：尽管已知的生活质量（QOL）与终阶段肾脏疾病（ESRD）相关的缺陷，但很少有尝试制定策略来改善ESRD呼吸肾脏移植的成年人的QOL。该研究计划的长期目标是更好地了解如何增强QOL，确定QOL变化的机制，以确定哪些患者从QOL干预中受益最大，并确定QOL益处是否可以超越移植。本应用的目的是确定生活质量疗法（QOLT）在等待肾移植的ESRD治疗成年人中的有效性，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Qolt可以改善等待肺移植的患者的质量，心理功能和社会亲密关系。该申请旨在检查是否可以与正在等待肾脏移植的ESRD的成年人有效地适应和实施这种干预措施。中心假设是，通过针对特定生命领域的改善，Qolt在QOL，心理功能和患者护理者的关系方面产生了显着的临床益处。该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）检查种族Qolt的差异效果（白人，非裔美国人）； 3）评估多站点R01应用的可行性。在第一个目标下，等待肾移植的成年人将被随机地接受QT，支持治疗（ST）或标准护理（SC）。主要结果将是治疗后1和12周的QOL，心理功能和社会亲密关系的变化。在第二个目标下，将仔细研究种族和干预结果之间的关系。在第三个目标下，将收集损耗率，流失率，治疗师遵守治疗方案以及参与者满意度等级，以评估在开发较大的多站点临床试验R01应用之前的方案更改的需求。这项研究具有创新性，因为它是最早评估理论上驱动的心理干预以在ESRD和肾移植背景下特异性改善QOL的人之一。拟议的研究很重要，因为预计它将提高和扩展对ESRD患者如何改善QOL的理解。与公共卫生相关：这是一个重要且不受欢迎的领域。随着肾移植的等待时间很长，可以使用有效的QOL干预措施来改善所有否则医疗残疾并等待移植的患者的福祉质量。这些好处有可能扩大单独移植的质量结果。