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Educating Missouri Patients About Preemptive Living Donor Transplantation

2011年9月13日 更新者:Amy Waterman, PhD、Washington University School of Medicine

Educating Missouri Patients About Preemptive Living Donor Transplantation: A Randomized Controlled Trial

This study is a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue preemptive living donor transplant (PLDT) and PLDT rates.

研究概览

详细说明

Preemptive living donor transplant (PLDT), where renal patients get a living donor transplant before their kidneys fail, has better graft survival and lower mortality rates than living donor transplant following dialysis. However, not all renal patients and their living donors know about or consider living donation before a patient starts dialysis; To date, patients and donors presenting for PLDT are more likely to be Caucasian, of higher socioeconomic status, and more knowledgeable about transplant. To reach all patients newly diagnosed with kidney disease, the Missouri Kidney Program conducts a community Patient Education Program (PEP) outlining patients' transplant and dialysis options. Since 1994, approximately 2000 Missouri patients newly diagnosed with kidney disease and their family members have attended 2-day PEP classes. However, the current PEP transplant module does not significantly increase patients' willingness to pursue PLDT. Through a previous HRSA grant, Dr. Waterman designed the "Explore Transplant" education program based on Prochaska's Transtheoretical Model of Behavioral Change and her previous research to address key gaps in patients' living donation knowledge and to motivate patients to consider living donation. If funded, this study would conduct a group-randomized controlled trial to explore whether improved community transplant education for renal patients not yet on dialysis could increase patients' willingness to pursue PLDT and PLDT rates. Secondary objectives of the study are: (2) to increase rural and minority patients' access to transplant education, and (3) to describe racial, social, economic, and other influences affecting patients' PLDT willingness. The study design is a group-randomized controlled trial of 300 patients in 30 PEP classes in St. Louis, Springfield, and Kansas City, MO; patients and their family members in 15 classes will be randomized to receive the "Explore Transplant" education module, while 15 control classes will receive the traditional PEP transplant education. Across the education and control PEP classes we will compare: (1) increased willingness to pursue PLDT using baseline and follow-up attitudinal patient surveys, and (2) rates of living donation by tracking whether patients and their living donors present to any Missouri transplant center. At the conclusion of the study, we will have learned important information about how to reach and educate patients who have not yet begun dialysis and have developed a PLDT program that could be utilized in physicians' offices and by other organizations serving renal patients to increase living donation rates.

研究类型

介入性

注册 (实际的)

370

阶段

  • 不适用

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

    • Kansas
      • Overland Park、Kansas、美国、66212
        • Missouri Kidney Program
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University
      • Saint Louis、Missouri、美国、63122
        • Missouri Kidney Program
      • Springfield、Missouri、美国、65807
        • Missouri Kidney Program
      • Warrensburg、Missouri、美国、64093
        • Missouri Kidney Program

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Chronic kidney disease
  • Attend all 6 education modules
  • 18+ years of age
  • Have given consent by signing informed consent
  • Speak and understand English
  • Can read and understand questionnaires

Exclusion Criteria:

  • Patients who do not speak and understand English (material is presented orally)
  • Patients who cannot read and understand the questionnaires
  • Patients who are 17 years of age or younger

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

  • 主要用途:支持治疗
  • 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:Standard transplant education
Missouri Kidney Program's standard Patient Education Program (PEP) transplant module.
实验性的:Transplant education with video
Explore Transplant transplant module featuring video
1 hour standard transplant module is replaced with the Explore Transplant presentation and 20 minute video featuring transplant patients and donors
实验性的:Transplant education with speakers
Explore Transplant transplant module featuring live guest speakers.
1 hour standard transplant module is replaced with the Explore Transplant presentation and 3 live speakers: 1 deceased donor recipient, 1 living donor recipient and 1 living donor

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Willingness to pursue preemptive living donor transplant
大体时间:pre and post-class
pre and post-class

次要结果测量

结果测量
大体时间
Preemptive living donor transplant rates
大体时间:1-2 years
1-2 years

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:Amy D Waterman, PhD、Washington University School of Medicine

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

2008年9月1日

初级完成 (实际的)

2011年8月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2009年7月20日

首先提交符合 QC 标准的

2010年1月11日

首次发布 (估计)

2010年1月13日

研究记录更新

最后更新发布 (估计)

2011年9月15日

上次提交的符合 QC 标准的更新

2011年9月13日

最后验证

2011年9月1日

更多信息

与本研究相关的术语

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.

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