RELIVE Informed Consent Study

Study Overview
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Brief Summary
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An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.

Official Title
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Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study

Conditions
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Living Donors, Tissue Donors

Intervention / Treatment
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* Procedure: Organ Donation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living donor of a kidney or lung Exclusion Criteria: Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney Donors<br>People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama | Procedure: Organ Donation<br>* People in this study will donate either a lung or kidney<br>|
| Lung Donors<br>People who will donate a lung at the Washington University School of Medicine or the University of Southern California | Procedure: Organ Donation<br>* People in this study will donate either a lung or kidney<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Score 1 | Feelings of pressure to donate an organ on a 4-point scale e.g.; 1: No pressure to 4: A lot of pressure. | Change from 1 week prior to donation and 3 months after donation | 
| Questionnaire Score 2 | Understanding of the donor screening process on a 4-point scale e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation | 
| Questionnaire Score 3 | Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Score Secondary Endpoint 1 | Understanding of short-term medical risks of donation answered on a 4-point scale e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation | 
| Questionnaire Score Secondary Endpoint 2 | Understanding of long-term medical risks of donation expressed by donors on a scale of 1 to 4 e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation | 
| Questionnaire Score Secondary Endpoint 3 | Understanding of psychological risks of donation expressed by donors on a scale of 1 to 4 e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation | 
| Questionnaire Score Secondary Endpoint 4 | Understanding that recipients may have variable outcomes as expressed by donors on a scale of 1 to 4 e.g.; 1: No understanding to 4: Full understanding. | Change from 1 week prior to donation and 3 months after donation |