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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736268
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : August 7, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 13, 2008
First Posted Date  ICMJE August 15, 2008
Last Update Posted Date August 7, 2014
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization. [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
reduced mortality and fewer COPD-related physician visits or hospitalizations [ Time Frame: 4 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Composite measure of somatic quality of life [ Time Frame: 4 months and up to 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
reduced health care costs and improvements in quality of life [ Time Frame: 4 months and up to 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers
Official Title  ICMJE Telephone-based Intervention for Patients With COPD and Their Caregivers
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: CST
    Telephone-based Enhanced Coping Skills Training (CST)
    Intervention: Behavioral: Telephone-based Enhanced Coping Skills Training (CST)
  • UMC
    Usual Medical Care and COPD education and symptom monitoring (UMC)
    Intervention: Other: Usual Medical Care and COPD education and symptom monitoring (UMC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2014)
746
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2008)
600
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736268
Other Study ID Numbers  ICMJE Pro00003707
2R01HL065503-06A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP