Telephone-based Intervention for Patients With COPD and Their Caregivers
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| City: |
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Columbus |
| State: |
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Ohio |
| Zip Code: |
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43210 |
| Conditions: |
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Chronic Obstructive Pulmonary Disease |
| Purpose: |
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This study is an NIH-funded clinical trial conducted at Duke University Medical Center and
Ohio State University. The purpose of this study is to examine the effects of a
telephone-based, care-giver assisted, coping skills training (CST) program in patients with
Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD
patients and their caregivers to deal better with the stress of lung disease. This study
will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving
quality of life compared to a Usual Medical Care plus COPD education and symptom management
control group; 2) That enhanced CST will be associated with better medical outcomes (i.e.,
greater survival and fewer COPD-related physician visits or hospitalizations) compared to
Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of
life and survival will be mediated by increased functional capacity and better coping.
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| Study Summary: |
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This proposed study builds upon our prior research by: a) adapting and refining our CST
protocol, which was effective in improving psychosocial adjustment in patients awaiting lung
transplantation, to a broader population of patients with COPD who are not immediate
candidates for lung transplantation; b) enhancing our intervention to improve functional
capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on
medical expenditures; and d) including caregivers in an enhanced CST intervention.
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| Criteria: |
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Inclusion Criteria:
- male or female outpatients 21 years of age or older
- a diagnosis of COPD
- FEV1 25% or greater of predicted value
- FEV1/FVC <70%
- capacity to give informed consent and follow study procedures
Exclusion Criteria:
- dementia
- psychotic features including delusions or hallucinations
- acute suicide or homicide risk
- other illness (e.g., cancer) that is likely to cause death within 3 years
- unstable angina
- congestive heart failure stage III - IV by NYHA classification
- active involvement in pulmonary rehabilitation or a formal exercise program
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| NCT ID: |
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NCT00736268 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Columbus, Ohio 43210
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 21, 2013 |
| Modifications to this listing: |
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