Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT00736268
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT00736268
Study Brief:
Protocol Section:
NCT00736268