Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effectiveness of an Automated Walking Program Targeting Veterans With COPD
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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