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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kidney Donors | People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama |
| |
| Lung Donors | People who will donate a lung at the Washington University School of Medicine or the University of Southern California |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organ Donation | Procedure | People in this study will donate either a lung or kidney |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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People who will be donating at kidney at the University of Minnesota, Mayo Clinic, or University of Alabama or people who will be donating a lung at University of Washington Medical School or the University of Southern California
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Valapour, MD | University of Minnesota, Center for Bioethics | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21158924 | Result | Valapour M, Kahn JP, Bailey RF, Matas AJ. Assessing elements of informed consent among living donors. Clin Transplant. 2011 Mar-Apr;25(2):185-90. doi: 10.1111/j.1399-0012.2010.01374.x. Epub 2010 Dec 16. |
| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SDY292 | Individual Participant Data Set | View IPD |
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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| ID | Term |
|---|---|
| D009927 | Tissue and Organ Procurement |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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 |
| Division of Allergy, Immunology, and Transplantation (DAIT) website | View source |
ImmPort study identifier is SDY292 |
| SDY292 | Study Protocol | View IPD | ImmPort study identifier is SDY292. The study protocol is available in the Design tab section. |