Long Term Follow up of the LTOG Cohort

Study Overview
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Brief Summary
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The purpose of the study is to follow participants who enrolled in the Lung Transplant Outcomes Group. Clinical data, functional assessments, and surveys will be collected to determine long term graft function and functional status of lung transplant recipients.

Detailed Description
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This project will involve both retrospective and prospective data collection from participants enrolled in the LTOG cohort studies. We will perform long-term Chronic Lung Allograft Dysfunction (CLAD) phenotyping of lung transplant recipients who participated in the LTOG cohort studies utilizing data collected for routine clinical visits. Surviving lung transplant recipients who participated in the LTOG cohort studies will be recruited to enroll in the longitudinal portion of the project. The longitudinal component will include follow-up data collection at 6 month intervals while alive until study termination, study withdrawal, or no longer being seen for follow-up at the participating center. Follow-up data collection will include clinical data collected by study coordinators by reviewing medical records, functional assessment through administration of the Short Physical Performance Battery (SPPB), blood collection and surveys. Data from this project will be linked to data and samples collected during the LTOG cohort or ancillary studies.

Official Title
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Long Term Follow up of the Lung Transplant Outcomes Group Cohort

Conditions
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Lung Transplant Failure and Rejection

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Long-term phenotyping of CLAD Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers Long-term functional status and well-being Lung transplant recipients who have previously enrolled in the LTOG cohort studies at one of the participating centers Alive Exclusion Criteria Long-term phenotyping of CLAD Lung transplant recipient not enrolled in LTOG cohort research studies Long-term functional status and well-being Lung transplant recipient not enrolled in the LTOG cohort research studies Lung transplant recipient not receiving post-transplant follow-up care at a participating LTOG center

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Lung Allograft Dysfunction (CLAD) phenotyping | Change in pulmonary function measured by serial pulmonary function tests (PFTs) and data collected at clinical care visits will be used to assess CLAD. | From date of transplant to the development of CLAD, up to 25 years | 
| Functional status phenotyping | Change in functional status will be measured by the Short Physical Performance Battery (SPPB). The SPPB is a 3-construct measure that includes gait speed, chair stands, and balance. Each construct is scored from 0 - 4 yielding an aggregate score ranging from 0 - 12. Lower SPPB scores reflect increased frailty. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years | 
| Well being phenotyping-LT-VLA | Change in well being will be measured by patient reported outcomes including the LT-VLA scale. The LT-VLA scale presents a list of activities and asks respondents to rate their difficulty in performing each one on a 4-point scale. A higher score on the LT-VLA indicates more disability. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years | 
| Well being phenotyping-LT-QOL | Change in well being will be measured by patient reported outcomes including the Lung Transplant Quality of Life (LT-QOL) survey. The Lung Transplant Quality of Life (LT-QOL) survey will be used to measure disease specific QOL. The LT-QOL utilizes 5 point scales for all items. The general quality of life scale is scored so that higher scores indicate better QOL. | From date of transplant to until study termination, withdrawal, or no longer being seen for follow-up at the participating center, up to 25 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic lung allograft dysfunction, Functional status, Lung transplantation