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Internet-Based and Established Dyspnea Self-Management Programs in Chronic Obstructive Pulmonary Disease (COPD) Patients

2007年8月13日 更新者:Robert Wood Johnson Foundation

Comparing the Effects of an Internet-Based to an Established Dyspnea Self-Management Program on Dyspnea, Exercise Behavior, and Pulmonary Exacerbations in Patients With COPD

The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

研究概览

详细说明

Despite optimal medical treatment, people with chronic obstructive pulmonary disease (COPD) continue to experience dyspnea or shortness of breath. This study will evaluate two different ways to provide education and support to help patients manage their shortness of breath. One program will be conducted in a face-to-face setting and a second through the Internet. The main difference between the two programs is the way they are administered. The education, exercise, and monitoring components are the same. The overall goal of this study is to find out whether the two programs are comparable in their effect on shortness of breath (dyspnea) with activities of daily living, exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. Perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization will also be measured at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

研究类型

介入性

注册 (实际的)

50

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

    • California
      • San Francisco、California、美国、94143-0610
        • University of California
    • Washington
      • Seattle、Washington、美国、98195-7266
        • University of Washington

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of COPD, clinically stable for 1 month;
  • Spirometry results showing at least mild disease (FEV1/FVC < 70% and FEV1 < 80% predicted after bronchodilator);
  • ADL limited by dyspnea;
  • Ability to speak English and sign consent form;
  • Actively use computer and the Internet;
  • Maintain O2 saturation > 85% on < 6 L/min of nasal oxygen during the six minute walk;
  • Understands and is able to rate shortness of breath during exercise

Exclusion Criteria:

  • Active symptomatic illness other than COPD;
  • Formal pulmonary rehabilitation training in the past 6 months

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:单身的

研究衡量的是什么?

主要结果指标

结果测量
Dyspnea
Exercise adherence and performance
Pulmonary exacerbations

次要结果测量

结果测量
卫生资源利用
Perception of support
Self-efficacy for exercise and managing dyspnea

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:Virginia Carrieri-Kohlman, RN DNSc、University of California, San Francisco
  • 首席研究员:Huong Q Nguyen, RN PhD、University of Washington

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2003年9月1日

研究完成 (实际的)

2007年6月1日

研究注册日期

首次提交

2005年1月29日

首先提交符合 QC 标准的

2005年1月28日

首次发布 (估计)

2005年1月31日

研究记录更新

最后更新发布 (估计)

2007年8月14日

上次提交的符合 QC 标准的更新

2007年8月13日

最后验证

2007年8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.

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