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Advanced eHealth for Chronic Obstructive Pulmonary Disease (COPD) in Colorado

2012年10月3日 更新者:University of Colorado, Denver

Phase 3 Clinical Trial Studying the Efficacy of a Proactive Integrated Approach to Care in Patients With Advanced COPD

Chronic obstructive pulmonary disease (COPD) is the 4th leading cause of death in the United States, affects 24 million people and is responsible for up to $32 billion annually in direct and indirect health care costs. Based upon these national COPD prevalence data, we estimate that 483,000 Coloradans have COPD (193,000 diagnosed and 290,000 undiagnosed), and that the care of these patients costs up to $490 million annually. Therefore, to alter the impact of COPD on the State and People of Colorado, we propose to introduce a telephone-dependent, internet-supported, self-monitoring "eHealth" management system in both urban and rural Colorado settings in order to decrease healthcare utilization, improve the management of COPD based upon current national guidelines, improve quality of life, reduce health care costs decrease COPD exacerbations. We base this program on a successful clinical pilot study, performed at the University of Colorado Hospital (UCH) during 2004-2005, which demonstrated dramatic improvements in quality of life and decreased health care costs. We propose to enroll patients with advanced COPD, or a history of COPD exacerbations, because these are the patients with the highest healthcare costs, the greatest disability, and the highest mortality. The ultimate goal of this project is to demonstrate the feasibility and efficacy of this proactive management strategy as it is disseminated throughout urban and rural Colorado. In this first phase we will target two Denver Metro sites, UCH and Kaiser-Permanente (KP), and rural sites (to be determined). We chose these urban sites because of their strong interest in enacting the eHealth Program, because of their organized systems of healthcare delivery and because of the numbers of COPD patients that they serve. We are particularly enthusiastic about the application of this technology to rural, underserved areas, because this approach has the potential to dramatically improve delivery of healthcare to a large portion of Colorado that is chronically plagued by inadequate health care networks and lack of specialty care. More broadly, we are enthusiastic about the prospect that eHealth programs may hold the potential to improve healthcare delivery for many chronic illnesses, in addition to COPD.

研究概览

研究类型

介入性

注册 (实际的)

511

阶段

  • 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

    • Colorado
      • Aurora、Colorado、美国、80045
        • University Of Colorado Hospital
      • Denver、Colorado、美国、80218
        • Kaiser Permanente

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

40年 及以上 (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:

  • COPD Diagnosis per GOLD Guidelines
  • Airflow obstruction on spirometry defined as an FEV1/FVC less than or equal to 70% and an FEV1 less than or equal to 50% predicted, or an FEV1 greater than 50% predicted with a history of a COPD exacerbation within the previous year.
  • Standard telephone access
  • US Citizen and Colorado resident

Exclusion Criteria:

  • Asthma
  • Co-existing conditions that are likely to cause death within two years, CXR evidence of interstitial lung disease or other pulmonary diagnoses at the time of enrollment, end-stage liver disease, end-stage renal disease, end-stage muscle disease, HIV disease or dementia.

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: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
实验性的:Proactive Integrated Care
COPD-specific education, self-management instruction, remote monitoring and enhanced communication with a coordinator
Comparison of the effect of COPD education, self-management instruction, home monitoring with a Health Buddy Telemonitor, pulse oximeter, pedometer and spirometer, and enhanced communication with a study coordinator (cell phone access)
有源比较器:Standard Care Control
No intervention other that measurements taken at 0, 3, 6 and 9 months of the study.
No intervention was made. Data measurements were taken at 0, 3, 6 and 9 months, as in the active intervention group.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
医疗保健利用
大体时间:9个月
9个月

次要结果测量

结果测量
大体时间
Quality of Life by St. Georges Respiratory Questionnaire
大体时间:3, 6 and 9 months
3, 6 and 9 months
Guideline-based medical therapy
大体时间:9 months
9 months
Exercise capacity
大体时间:9 months
9 months
Oxygen utilization and pre-and post-exercise oxygen saturations
大体时间:9 months
9 months
Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index
大体时间:9 months
9 months
Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)
大体时间:9 months
9 months
Smoking status
大体时间:9 months
9 months
Pulmonary rehabilitation
大体时间:9 months
9 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:William Vandivier, MD、University of Colorado, Denver

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

2006年9月1日

初级完成 (实际的)

2007年8月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2010年1月6日

首先提交符合 QC 标准的

2010年1月7日

首次发布 (估计)

2010年1月8日

研究记录更新

最后更新发布 (估计)

2012年10月5日

上次提交的符合 QC 标准的更新

2012年10月3日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 06-0587
  • 07 FLA 00834 (其他标识符:CDPHE)

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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