Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Telephone-based Intervention for Patients With COPD and Their Caregivers
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.
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.
Overall, 746 participants (patients and caregivers) were consented for participation into this study from both Duke University Medical Center and Ohio State University. Of these, 326 patients were randomized and participated in the study intervention along with 252 consented participants who acted as a caregiver; in total 578 participants (patients and caregivers) were involved with the study intervention. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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