RELIVE Informed Consent Study

Living Donors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742234
• Other study ID #: DAIT RELIVE 03
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: March 23, 2017
• Start date: August 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 624
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Living donor of a kidney or lung

Exclusion Criteria:

• Unable to give informed consent

Related Conditions & MeSH terms

• Living Donors
• Tissue Donors

Intervention

Procedure:
• Organ Donation
People in this study will donate either a lung or kidney

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT) website
•   National Institute of Allergy and Infectious Diseases (NIAID) website