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临床试验/NCT01044927
NCT01044927已完成3 期

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

University of Colorado, Denver4 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
511
试验地点
4
主要终点
Healthcare utilization

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Healthcare utilization

时间窗: 9 months

次要结局

  • Oxygen utilization and pre-and post-exercise oxygen saturations(9 months)
  • Quality of Life by St. Georges Respiratory Questionnaire(3, 6 and 9 months)
  • Guideline-based medical therapy(9 months)
  • Exercise capacity(9 months)
  • Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) index(9 months)
  • Symptoms including cough, sputum production and dyspnea (modified Medical Research Council (MMRC) MMRC Dyspnea Scale)(9 months)
  • Smoking status(9 months)
  • Pulmonary rehabilitation(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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