Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00736268
First received: August 13, 2008
Last updated: August 6, 2014
Last verified: August 2014
  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.

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 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite measure of somatic quality of life [ Time Frame: 4 months and up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 746
Study Start Date: August 2008
Primary Completion Date: May 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:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736268

Locations
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
Sponsors and Collaborators
Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00736268     History of Changes
Other Study ID Numbers: Pro00003707, 2R01HL065503-06A1
Study First Received: August 13, 2008
Last Updated: August 6, 2014
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
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014