Stepping up to Health - for Veterans With Chronic Obstructive Pulmonary Disease (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.
Chronic Obstructive Pulmonary Disease (COPD)
Behavioral: automated internet-mediated walking program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Effectiveness of an Automated Walking Program Targeting Veterans With COPD|
- Self-Reported Respiratory-Specific Quality of Life [ Time Frame: assessments taken at four months and twelve months from randomization ] [ Designated as safety issue: No ]
- Self Reported Dyspnea [ Time Frame: four months and twelve months from enrollment ] [ Designated as safety issue: No ]
- Days of Hospitalization [ Time Frame: assessed at twelve months from enrollment ] [ Designated as safety issue: No ]
- Increase in Average Daily Step Counts [ Time Frame: during the final month of the intervention ] [ Designated as safety issue: No ]
- Goal Commitment, Intervention Reach, Participant Retention, Participant Satisfaction & Adverse Events Rates [ Time Frame: four months and twelve months from enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
participants in the intervention arm are asked to participate in a walking program
Behavioral: automated internet-mediated walking program
intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
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. 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. An internet-mediated self-management program for veterans with COPD that focuses on walking could be disseminated widely at low marginal cost to any veteran with COPD who has internet access.
The proposed research is designed to test the effectiveness of an automated internet-mediated walking program for veterans with COPD on improving health related quality of life and reducing days of hospitalization. Additionally, the proposed research will compare measures of intervention reach, participation and satisfaction between urban and rural veterans.
This study will recruit approximately 300 participants nationwide by mail and randomly selected from VA medical databases to balance patients from rural and urban zip codes. Participants will be adult VA patients diagnosed with COPD who are also sedentary, ambulatory, have a physician to provide medical clearance, and who have access to a PC computer with an internet connection for e-mail. Interested participants will be directed to a secure VA website where they provide a waiver of signed informed consent and complete a baseline survey. Research staff will obtain medical clearance for walking from patients' designated providers. Participants will then be mailed a pedometer and information to enroll the Stepping Up to Health internet-mediated walking program. At 4 and 12 months, participants will complete a questionnaire measuring patient satisfaction, perceived benefits with the walking website, and the occurrence of any walking related adverse events.
The study is a two-arm randomized controlled trial of an automated internet-mediated walking program targeting veterans with COPD. The two arms are 1) SUH for COPD and 2) wait list control. All study procedures will be delivered remotely including recruitment, consent, medical clearance, intervention delivery and outcome assessment. Equal numbers of urban and rural veterans will be invited, allowing comparisons of intervention reach, participation and satisfaction between urban and rural veterans
Recruitment began December 2011, and is expected to continue through the fall of 2012. To date we have consented 292 patients and randomized 151.
|United States, Michigan|
|VA Ann Arbor Healthcare System|
|Ann Arbor, Michigan, United States, 48113-0170|
|Principal Investigator:||Caroline R Richardson, MD||VA Ann Arbor Healthcare System|