Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers
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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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Behavioral: Telephone-based Enhanced Coping Skills Training (CST) Other: Usual Medical Care and COPD education and symptom monitoring (UMC) |
| Study Type: | Interventional |
| 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 |
- reduced mortality and fewer COPD-related physician visits or hospitalizations [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- reduced health care costs and improvements in quality of life [ Time Frame: 4 months and up to 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CST
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.
|
|
UMC
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.
|
Detailed Description:
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: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00736268 History of Changes |
| Other Study ID Numbers: | Pro00003707, 2R01 HL065503-06A1 |
| Study First Received: | August 13, 2008 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Lung Disease Chronic Bronchitis Emphysema |
Caregiver stress COPD Chronic Obstructive Pulmonary Disease |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013