BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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.

FINDINGS/RESULTS:
Participants included 239 randomized Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean SGRQ Total Score was; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220). There were no significant differences in baseline characteristics between study arms. One patient was dropped due to being an extreme outlier at 4 months on both step counts and SGRQ change.

For the 4 month data, we used a complete case analysis. Two hundred and twenty-one participants had complete SGRQ data at 4 months; 5 additional patients had responses that allowed calculation of at least one domain score. Those within the intervention group showed significant improvement in SGRQ-TS by 3.2 units (P<0.001). There was no significant difference in SGRQ-TS (2.3 units, P=0.1) between the two groups. A greater proportion of persons in the intervention than in the control group had at least a 4-unit improvement in SGRQ-TS (53% vs 39%, P=0.05). For domain scores, Symptoms improved by 7.2 units (P<0.001) and Impacts by 2.8 units (P<0.05) among those in the intervention group. Those within the control group showed no significant changes. Compared to control, those in the intervention had an improvement of 4.6 units (P=0.046) for Symptoms and 3.3 units (P=0.049) for Impacts scores. There was no significant difference in Activities score (0.6 unit, P=0.78) between the two groups.

Two hundred and ten out of the 238 study participants had step-count data at 4 months, with
201 meeting the study criteria for valid 4-month daily step counts. Those in the intervention group showed significant increase in their daily step count on average by 447 steps while those in the control group had a decrease in their daily step count of 346 steps. The difference in step counts at four months between the two groups was significant (779 per day; P=0.005) adjusting for baseline rural/urban status, and MMRC dyspnea score.

For the 12 month data, we used an all case analysis. At 12 months, 209 study participants had complete SGRQ data at 12 months, and 4 additional patients had responses that allowed calculation of at least one domain. Those within the intervention group showed significant improvement in SGRQ-TS by 2.5 units (P=0.01). For domain scores, Symptoms improved by 3.2 units (P=0.02) and Impacts by 3.4 units (P<0.01) among those in the intervention group from baseline. Those within the control group showed no significant changes. Compared to control, those in the intervention no longer showed significant improvement at 12 months on any domain scores, and continued to show no improvement on TS.

At 12 months, there was no difference between or within arms from baseline for step counts. Surprisingly, the control group significantly increased daily step counts by 673 (P<.05) between 4 and 12 months.

Self-reported hospitalizations are not significantly different between arms at one year post randomization.

IMPACT:
Chronic Obstructive Pulmonary Disease (COPD) is a common disabling chronic condition that is more prevalent in veterans than in the general population. Limitations in daily activities due to reduced exercise tolerance along with frequent hospitalizations for COPD exacerbations contribute to poor quality of life and increased health care costs. Veterans in the Internet-mediated intervention, compared with the control group, reported improvement in two out of three subscales of the SGRQ health related quality of life and increased their step counts at 4 months. However, these results were not sustained at 12 months. Further work is needed to understand how to sustain improvements in the long term in this population. Nonetheless, automated Internet-mediated interventions can be used to deliver care with to underserved rural Veterans or those who do not have access to facility-based pulmonary rehabilitation programs.

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External Links for this Project

NIH Reporter

Grant Number: I01HX000332-01
Link: https://reporter.nih.gov/project-details/7870166

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PUBLICATIONS:

None at this time.

DRA: Lung Disorders
DRE: Treatment - Observational, Prevention, Treatment - Comparative Effectiveness
Keywords: Chronic lung disease, Exercise, Quality of life
MeSH Terms: none