Effectiveness of an Automated Walking Program Targeting Veterans With COPD
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| City: |
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Ann Arbor |
| State: |
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Michigan |
| Zip Code: |
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48113 |
| Conditions: |
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Chronic Obstructive Pulmonary Disease (COPD) |
| Purpose: |
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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.
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| Study Summary: |
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Background:
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.
Objectives:
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.
Methods:
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
Status:
Recruitment began December 2011, and is expected to continue through the fall of 2012. To
date we have consented 292 patients and randomized 151.
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosis codes of quadriplegia and paraplegia or pregnancy-related diagnoses or
procedures within the previous year will be excluded from potential participant pool
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| NCT ID: |
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NCT01102777 |
| Primary Contact: |
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Principal Investigator
Caroline R Richardson, MD
VA Ann Arbor Healthcare System
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| Backup Contact: |
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N/A |
| Location Contact: |
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Ann Arbor, Michigan 48113
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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