RELIVE Informed Consent Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Kidney Donors People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama |
Procedure: Organ Donation
People in this study will donate either a lung or kidney
|
| Lung Donors People who will donate a lung at the Washington University School of Medicine or the University of Southern California |
Procedure: Organ Donation
People in this study will donate either a lung or kidney
|
Outcome Measures
Primary Outcome Measures
- Questionnaire Score 1 [Change from 1 week prior to donation and 3 months after donation]
Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."
- Questionnaire Score 2 [Change from 1 week prior to donation and 3 months after donation]
Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
- Questionnaire Score 3 [Change from 1 week prior to donation and 3 months after donation]
Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
Secondary Outcome Measures
- Questionnaire Score Secondary Endpoint 1 [Change from 1 week prior to donation and 3 months after donation]
Understanding of short-term medical risks of donation answered on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."
- Questionnaire Score Secondary Endpoint 2 [Change from 1 week prior to donation and 3 months after donation]
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."
- Questionnaire Score Secondary Endpoint 3 [Change from 1 week prior to donation and 3 months after donation]
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."
- Questionnaire Score Secondary Endpoint 4 [Change from 1 week prior to donation and 3 months after donation]
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."
Eligibility Criteria
Criteria
Inclusion Criteria:
- Living donor of a kidney or lung
Exclusion Criteria:
- Unable to give informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Study Chair: Maryam Valapour, MD, University of Minnesota, Center for Bioethics
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- National Institute of Allergy and Infectious Diseases (NIAID) website
- Division of Allergy, Immunology, and Transplantation (DAIT) website
Publications
None provided.- DAIT RELIVE 03