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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00675376
First received: May 7, 2008
Last updated: August 19, 2013
Last verified: August 2013

May 7, 2008
August 19, 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 ] [ Designated as safety issue: No ]
Assess the effectiveness of transplant, for patients with COPD, in the new donor lung allocation system [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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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.
 
Enrolling by invitation
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
Both
21 Years to 67 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00675376
564, R01HL083067, R01 HL083067-01
No
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

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