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:
Participants were followed for 12 months to investigate the efficacy of the intervention in assisting patients with initiating and maintaining a regular walking program and improving health related quality of life. Eligible and consented patients wore a pedometer to obtain one week of baseline data and then were randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm received iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls were notified that they were enrolled, but that their intervention would start in one year; however, they kept the pedometer and had access to a static webpage. Both groups completed on-line survey assessments at baseline, 4, and 12 months, and were asked to report adverse events on a regular basis. The primary outcome was changes in health related quality of life, as measured using the St George's Respiratory Questionnaire (SGRQ), a disease-specific instrument in patients with COPD. Secondary outcomes included days of hospitalization during the one-year intervention period, changes in average daily steps as measured using the study pedometer, self-reported dyspnea, intervention reach, and adverse event rates. The analysis was conducted based \[on the original randomized treatment assignment regardless of participation (an intent-to-treat analysis) and included both a complete case analysis as well as an all case analysis using a linear mixed-effects model. Between-group differences in change scores (4 months or 12 months) were estimated after adjusting for baseline values of the outcome variables.
Status:
This study is completed. Data analysis and manuscript preparation continue.
