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Uncertainty Management Intervention

2014年2月6日 更新者:Duke University

Uncertainty Management Intervention for Patients Awaiting Liver Transplant

The goal of this study is to improve symptoms and quality of life for end-stage liver disease patients awaiting a liver transplant and their caregivers by providing them with the resources and tools to self-manage their complex concerns.

研究概览

详细说明

Hepatitis C Virus is the most common blood-borne infection in the U.S., affecting at least 4 million individuals, with more than 19,000 new cases occurring each year. Further, the CDC has projected a fourfold increase in the number of chronic hepatitis C patients between 1990 and 2015, and these patients are at risk for developing end stage liver disease (ESLD). By 2015 an estimated 375,000 chronic hepatitis C patients will develop cirrhosis and progress to ESLD, representing the majority of individuals who need liver transplants. ESLD is a life-limiting illness, and patients are told that, without a liver transplant, they may die.

This 5 year randomized controlled trial will test the efficacy of an Uncertainty Management Intervention delivered via telephone by a nurse to the patient and caregiver. An attention control group of patients and caregivers will receive phone calls to discuss their experience of awaiting a liver transplant. Based on the problems and concerns of patients waiting for a liver transplant and the prior success of the Intervention for patients dealing with serious chronic illness, we believe the Uncertainty Management Intervention adapted specifically for ESLD patients will lead to significant improvements in patients' and caregivers' abilities to manage the symptoms and distress associated with ESLD and the process of awaiting liver transplant.

The specific aims are to: 1) examine the effects of the Uncertainty Management Intervention on patient outcomes of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and QOL compared to an attention control group receiving calls to discuss their disease experience; 2) explore the effects of the Intervention on caregiver outcomes of uncertainty management, self-efficacy for helping the patient manage symptoms, and better QOL compared to an attention control group; 3) identify characteristics of individuals for whom the intervention is particularly effective.

Waiting for a liver transplant under conditions of uncertainty is a harrowing experience for patients and caregivers, yet there have been few attempts to test nursing interventions for ESLD patients. The overall goal of this project is to provide these patients and their caregivers the tools to self-manage their complex concerns. The anticipated outcome is ESLD patients awaiting liver transplant benefit from the Uncertainty Management Intervention, thus providing new knowledge for practitioners and policy makers.

研究类型

介入性

注册 (实际的)

288

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

    • Nebraska
      • Omaha、Nebraska、美国、68198
        • The University of Nebraska Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina-Chapel Hill
      • Durham、North Carolina、美国、27705
        • Duke University
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15261
        • The University of Pittsburgh

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

18年 及以上 (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 (patient):

  • Diagnosis of ESLD and on the liver transplant waiting list
  • Receiving care at a Liver Clinic in the United States
  • 18 years of age or older
  • MELD greater than or equal to 11
  • Able to read and speak English
  • No major cognitive impairment
  • Not a recipient of a prior transplant (any organ)
  • Has a caregiver willing to participate

Inclusion Criteria (caregiver):

  • 18 years of age or older
  • Able to read and speak English
  • Provides care to a patient meeting the above criteria

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:卫生服务研究
  • 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
其他:Uncertainty Management Intervention
The Uncertainty Management Intervention will consist of six 30-minute phone calls with a study educator to discuss issues of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and quality of life.
Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
其他:Comparison Conditions for Liver Disease
Six 30-minute telephone calls that provide structured education about liver disease.
Six 30-minute telephone calls that provide structured education about liver disease.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Uncertainty Management
大体时间:Five months
Five months

次要结果测量

结果测量
大体时间
Symptom control
大体时间:Five months
Five months
Quality of life
大体时间:Five months
Five months
Psychological distress
大体时间:Five months
Five months

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 Tulsky, MD、Duke University School of Nursing
  • 首席研究员:Donald Bailey, PhD、Duke University School of Nursing
  • 首席研究员:Annette Devito Dabbs, PhD, RN、The University of Pittsburgh
  • 首席研究员:Paul H. Hayashi, MD, MPH、University of North Carolina, Chapel Hill
  • 首席研究员:Laurel Williams-Salonen, RN,MSN,CCTC、The University of Nebraska 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

2010年2月1日

初级完成 (实际的)

2013年9月1日

研究完成 (实际的)

2013年9月1日

研究注册日期

首次提交

2009年7月10日

首先提交符合 QC 标准的

2009年7月10日

首次发布 (估计)

2009年7月14日

研究记录更新

最后更新发布 (估计)

2014年2月7日

上次提交的符合 QC 标准的更新

2014年2月6日

最后验证

2014年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00007468
  • 1P01NR010948-01 (美国 NIH 拨款/合同)

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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