Quality of Life Therapy for Adults With ESRD Awaiting Renal Transplantation
2012年1月5日 更新者:James Rodrigue、Beth Israel Deaconess Medical Center
The purpose of this study is to determine whether psychological intervention is effective in improving quality of life, mood, and relationships among adults with end-stage renal disease who are awaiting kidney transplantation.
研究概览
详细说明
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 research 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.
We now seek 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 is being 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 are being randomized to receive QOLT, Supportive Therapy (ST), or Standard Care (SC).
Primary outcomes are 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 are being 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 research is significant because it is expected to advance and expand understanding of how QOL can be improved in patients with ESRD.
研究类型
介入性
注册 (实际的)
65
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Massachusetts
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Boston、Massachusetts、美国、02215
- The Transplant Center, Beth Israel Deaconess Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female patients between 21 and 70 years of age
- Diagnosis of ESRD
- Wait-listed for deceased donor renal transplantation (primary transplant only)
- White or African American race
- Signed informed consent
- Primary caregiver identified as spouse or domestic partner
- Resides within 60 minutes of transplant center
Exclusion Criteria:
- Prior recipient of renal transplantation
- Prior recipient of other solid organ transplantation
- Wait-listed for combined kidney-pancreas transplantation
- Current substance abuse or dependency
- Currently hospitalized
- Current recipient of psychological intervention services
- Mental retardation
- Substantial cognitive impairment (score of 23 or less on the Mini-Mental State Examination)
- Communication difficulties (speech, hearing) so substantial that they would prevent patient from participating actively in one of the interventions (determined by transplant social worker)
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:标准护理
|
|
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实验性的:QOLT
Quality of Life Therapy (QOLT) 8 weekly individual counseling sessions
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8 weekly individual counseling sessions
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有源比较器:ST
Supportive Therapy (ST) 8 weekly individual counseling sessions
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8 weekly individual counseling sessions
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Primary: Scores on the following measures at 12 weeks post-intervention: Quality of Life Inventory, SF-36, KDQoL, CDC Activity Limitations Module, Hopkins Symptom Checklist, POMS, and Miller Social Intimacy Scale
大体时间:12 weeks
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12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:James R. Rodrigue, PhD、Beth Israel Deaconess Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年1月1日
初级完成 (实际的)
2009年7月1日
研究完成 (实际的)
2011年4月1日
研究注册日期
首次提交
2007年1月25日
首先提交符合 QC 标准的
2007年1月25日
首次发布 (估计)
2007年1月29日
研究记录更新
最后更新发布 (估计)
2012年1月6日
上次提交的符合 QC 标准的更新
2012年1月5日
最后验证
2012年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.