Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Telephone-based Intervention for Patients With COPD and Their Caregivers
Verified date | August 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 746 |
Est. completion date | |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - male or female outpatients 21 years of age or older - a diagnosis of COPD - FEV1 25%-80% 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Blumenthal JA, Babyak MA, Keefe FJ, Davis RD, Lacaille RA, Carney RM, Freedland KE, Trulock E, Palmer SM. Telephone-based coping skills training for patients awaiting lung transplantation. J Consult Clin Psychol. 2006 Jun;74(3):535-44. — View Citation
Emery CF, Leatherman NE, Burker EJ, MacIntyre NR. Psychological outcomes of a pulmonary rehabilitation program. Chest. 1991 Sep;100(3):613-7. — View Citation
Martinu T, Babyak MA, O'Connell CF, Carney RM, Trulock EP, Davis RD, Blumenthal JA, Palmer SM; INSPIRE Investigators. Baseline 6-min walk distance predicts survival in lung transplant candidates. Am J Transplant. 2008 Jul;8(7):1498-505. doi: 10.1111/j.1600-6143.2008.02264.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. | 4 years | No | |
Secondary | Composite measure of somatic quality of life | 4 months and up to 4 years | No |
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