 |
 |
 |
 |
 |
 |
 |
Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers
This study is currenly Recruiting patients.
Sponsored by:
Duke University
Purpose
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.
Study Type: Intervention
| Condition | Intervention | Phase |
|
Chronic Obstructive Pulmonary Disease |
Array: Array Array: Array | N/A |
Study Design:Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Official Title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Further Study Details:
Expected Total Enrollment:
Study Dates:August 2008 -
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.
Eligibility
Ages Eligible for Study- Min: 21 Years Max: N/A
Gender: Both
Criteria
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
Inclusion Criteria:
Exclusion Criteria:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00736268
Ohio
Ohio State University - Columbus, Ohio 43210
Charles F. Emery, Ph.D. 614-688-3061 emery.33@osu.edu
More Information
Record Last Reviewed:August 2009
Last Updated:August 4, 2009
Record First Recieved:August 13, 2008
ClinicalTrials.gov Identifier:NCT00736268
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
 |
 |