Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effectiveness of an Automated Walking Program Targeting Veterans With COPD
Verified date | December 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 307 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | VA Ann Arbor Healthcare System | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-Reported Respiratory-Specific Quality of Life | assessments taken at four months and twelve months from randomization | No | |
Secondary | Self Reported Dyspnea | four months and twelve months from enrollment | No | |
Secondary | Days of Hospitalization | assessed at twelve months from enrollment | No | |
Secondary | Increase in Average Daily Step Counts | during the final month of the intervention | No | |
Secondary | Goal Commitment, Intervention Reach, Participant Retention, Participant Satisfaction & Adverse Events Rates | four months and twelve months from enrollment | No |
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