Status:
TERMINATED
Bronchitis and Emphysema Advice and Training to Reduce Hospitalization
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
COPD
Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
EXECUTIVE SUMMARY: Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk o...
Detailed Description
EXECUTIVE SUMMARY: Purpose: To evaluate the efficacy and cost-effectiveness of a novel intervention incorporating self-management education, an action plan, and case-management to decrease the risk o...
Eligibility Criteria
Inclusion
- Population to be studied
- The study population consists of VA patients with COPD who receive some of their medical care at Veterans Affairs medical centers and were hospitalized for COPD in the last 12 months. To ensure that patients enrolled in the study receive regular care at the participating VA, we will include only patients enrolled in either the primary care or pulmonary clinic at the VA medical center and were seen at least once in the last year. This criterion should not significantly decrease the number of eligible patients because 90% of patients admitted for COPD in the VA had at least 1 outpatient visit to the VA primary care clinic in the year prior to their hospitalization based on data from the VA OPC in FY03.
- Diagnosis of COPD confirmed by all of the following:
- FEV1/FVC \< 0.70
- FEV1 \< 80%
- Age \> 40 years
- A current or past history of cigarette smoking (\> 10 pack-years)
- COPD hospitalization in the previous year
- Receives care at participating VA medical center
- Enrolled in either primary care or pulmonary clinic at the VA
- Seen at least once in the past year in either primary care or pulmonary clinic
- No COPD exacerbations in last 4 weeks
- English-speaking
- Access to telephone
Exclusion
- Primary clinical diagnosis of asthma
- Medical conditions affecting the ability to participate in the study such as:
- Comorbid illness likely to limit life expectancy \< 1 year
- Decompensated heart failure
- Dementia
- Uncontrolled psychiatric illness
- Participation in another clinical intervention trial in the previous 30 days
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT00395083
Start Date
July 1 2006
End Date
September 1 2010
Last Update
September 15 2014
Active Locations (22)
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1
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
2
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
3
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
4
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290