RELIVE Informed Consent Study

Completed

• Conditions: Living Donors; Tissue Donors
• Interventions: Procedure: Organ Donation

• Registration Number: NCT01742234
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 624

Inclusion Criteria

• Living donor of a kidney or lung

Exclusion Criteria

• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Donors	Organ Donation	People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama
Lung Donors	Organ Donation	People who will donate a lung at the Washington University School of Medicine or the University of Southern California

Primary Outcome Measures

Name	Time	Method
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."
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."

Secondary Outcome Measures

Name	Time	Method
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 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 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 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."