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Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Washington University School of Medicine.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675376
First Posted: May 9, 2008
Last Update Posted: August 20, 2013
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Washington University School of Medicine
May 7, 2008
May 9, 2008
August 20, 2013
January 2006
December 2014   (Final data collection date for primary outcome measure)
Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system [ Time Frame: Measured throughout the study ]
Assess the effectiveness of transplant, for patients with COPD, in the new donor lung allocation system [ Time Frame: Ongoing ]
Complete list of historical versions of study NCT00675376 on ClinicalTrials.gov Archive Site
Comparison of the effects of lung transplantation on the quality of life of patients with COPD in the new donor lung allocation system versus the old donor lung allocation system [ Time Frame: Measured throughout the study ]
Compare the effects of transplant on the quality of life of patients with COPD in the new donor lung allocation system and the old donor lung allocation system [ Time Frame: Ongoing ]
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Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
Lung Transplant for COPD: Outcomes/Technology
Most people undergoing lung transplantation have chronic obstructive pulmonary disease (COPD), a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. This study will enroll people with COPD who are undergoing a lung transplant to examine how their quality of life changes after the transplant procedure.

Lung transplantation is one treatment option for people with end-stage lung disease. The majority of people undergoing a lung transplant have COPD, and while transplantation can potentially improve survival and quality of life, it may also carry substantial risks, including surgical complications, infections, and pneumonia. The impact of lung transplantation on survival and quality of life has not been extensively studied. In the United States, the United Network for Organ Sharing (UNOS) is the organization that allocates donor lungs to lung recipients. Before 2005, the length of time that a candidate had been on the transplant waiting list was the major determining factor for receiving a donor lung. In mid 2005, the UNOS system changed and began prioritizing candidates on the basis of risk of death prior to lung transplantation and the probability of death within the first year after transplantation. The purpose of this study is to evaluate quality of life factors for lung transplant patients with COPD, both before and after the lung transplant procedure. In addition, quality of life of patients in the new UNOS allocation system will be compared with that of patients in the old UNOS allocation system.

This study will enroll all COPD patients undergoing an evaluation for lung transplantation at the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis, Missouri. Participants will attend study visits at the time of the transplant evaluation and again just prior to listing in the UNOS system. After the transplant, participants will attend study visits at Months 3 and 6 and then once a year for 5 years. During each study visit, participants will complete a computerized interview and health-related questionnaires that will assess quality of life factors, including social life, work life, and home life. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
All study participants will undergo evaluation in the lung transplant clinic at Washington University Medical Center and Barnes-Jewish Hospital. They must have the diagnosis of COPD predominantly due to emphysema.
  • Pulmonary Disease, Chronic Obstructive
  • Lung Transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
350
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Referred to the adult lung transplant program
  • Undergoing evaluation for lung transplantation
  • Very severe COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] class IV) that is predominantly due to emphysema
  • Able to read English
  • Able to adequately see a computer screen

Exclusion Criteria:

  • Diagnosis other than COPD
  • Inability to read English
Sexes Eligible for Study: All
21 Years to 67 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00675376
564
R01HL083067 ( U.S. NIH Grant/Contract )
R01HL083067-01 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Roger D. Yusen, MD, MPH Washington University School of Medicine, St. Louis
Washington University School of Medicine
August 2013