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临床试验/NCT01102777
NCT01102777已完成不适用

Effectiveness of an Automated Walking Program Targeting Veterans With COPD

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
2
主要终点
Self-Reported Respiratory-Specific Quality of Life

研究概览

简要总结

The purpose of this study is to assess the efficacy of an internet-mediated pedometer based intervention that is designed to increase walking and improve function among veterans with chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health-related quality of life at four-months and at one year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the effect of internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization. 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. The long-term objective of this research is to develop, evaluate and disseminate effective, low-cost interventions that improve quality of life for veterans, particularly rural veterans, managing complex chronic conditions.

详细描述

Background:

Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Individuals with COPD who undergo a facility-based, exercise-focused pulmonary rehabilitation program experience significant improvements in health related quality of life, dyspnea, and exercise tolerance as well as reduced rates of hospitalization. Unfortunately, only a small percent of individuals with COPD who could benefit from pulmonary rehabilitation have access to and participate in such programs. Moreover, the benefits of short-term pulmonary rehabilitation programs tend to diminish rapidly after the program ends. Rural veterans are less likely to have access to facility-based pulmonary rehabilitation than urban veterans. Health related quality of life in rural veterans with COPD is significantly worse than for veterans with COPD who live in urban areas.

Objectives:

The primary objective of this study was to assess the efficacy of an Internet-mediated, pedometer-based intervention designed to increase walking and health related quality of life for Veterans with COPD. The specific aims of this randomized controlled trial (RCT) with a wait list control were: 1) To test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health related quality of life at four months and at one year; 2) to estimate the effect of the internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization; and 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm.

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • Adult >= 40 years old
  • Diagnosis of COPD, emphysema or chronic bronchitis
  • Able to walk a minimum of one block
  • Sedentary, defined by less than 150 minutes of self-reported physical activity per week
  • Have a doctor or primary care provider in the VA who can provide medical clearance
  • Competent to give informed consent
  • Must be a regular email user (check weekly)
  • Have access to a computer with an internet connection, a USB port, and Windows XP or Vista

排除标准

  • Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or procedures within the previous year will be excluded from potential participant pool

结局指标

主要结局

Self-Reported Respiratory-Specific Quality of Life

时间窗: twelve months from randomization

Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.)

次要结局

  • Participant Retention(during study participation, up to twelve months)
  • Self Reported Dyspnea(twelve months from randomization)
  • Change in Average Daily Step Counts(baseline and final two weeks of the intervention and the two weeks post intervention.)
  • Study Reach Among Rural Participants(At baseline)
  • Goal Commitment for Intervention Participants(change from four months and twelve months from enrollment)
  • Change in Participant Satisfaction(four to twelve months of study participation)
  • Days of Hospitalization(during study participation, up to 12 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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