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
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive
Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Transplant for COPD: Outcomes/Technology

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: January 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  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: NCT00675376

Locations
United States, Missouri
Washington University School of Medicine and Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Roger D. Yusen, MD, MPH Washington University School of Medicine, St. Louis
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00675376     History of Changes
Other Study ID Numbers: 564, R01HL083067, R01 HL083067-01
Study First Received: May 7, 2008
Last Updated: August 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
COPD
Lung Transplant
Quality of Life
End Stage Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014