Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers
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|ClinicalTrials.gov Identifier: NCT00736268|
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : August 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Behavioral: Telephone-based Enhanced Coping Skills Training (CST) Other: Usual Medical Care and COPD education and symptom monitoring (UMC)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||746 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Telephone-based Intervention for Patients With COPD and Their Caregivers|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||May 2013|
Telephone-based Enhanced Coping Skills Training (CST)
Behavioral: Telephone-based Enhanced Coping Skills Training (CST)
Telephone-based Enhanced Coping Skills Training (CST) intervention will systematically train participants (and caregivers) in the use of coping skills for symptom management (i.e. activity pacing, pleasant activity scheduling, communications, relaxation, goal setting, imagery, calming self-statements, problem solving, and preventing and dealing with setbacks). Participants in the CST condition will receive 12 weekly 30 minute telephone sessions followed by 2 bi-weekly booster sessions for training in symptom management strategies. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.
Usual Medical Care and COPD education and symptom monitoring (UMC)
Other: Usual Medical Care and COPD education and symptom monitoring (UMC)
COPD usual care plus education and symptom monitoring control condition will participate in a weekly 15 minute phone call followed by 2 bi-weekly phone calls, assessing their health status and providing them with support and COPD education. COPD Education topics include types of lung disease, oxygen use, medication management, preventing infection, managing daily activities, and nutrition. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.
- Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. [ Time Frame: 4 years ]
- Composite measure of somatic quality of life [ Time Frame: 4 months and up to 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736268
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|