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RELIVE Informed Consent Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01742234
Enrollment
624
Registered
2012-12-05
Start date
2008-08-31
Completion date
2010-11-30
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living Donors, Tissue Donors

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.

Interventions

PROCEDUREOrgan Donation

People in this study will donate either a lung or kidney

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Living donor of a kidney or lung

Exclusion criteria

* Unable to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Questionnaire Score 1Change from 1 week prior to donation and 3 months after donationFeelings of pressure to donate an organ on a 4-point scale e.g.; 1: No pressure to 4: A lot of pressure.
Questionnaire Score 2Change from 1 week prior to donation and 3 months after donationUnderstanding of the donor screening process on a 4-point scale e.g.; 1: No understanding to 4: Full understanding.
Questionnaire Score 3Change from 1 week prior to donation and 3 months after donationUnderstanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; 1: No understanding to 4: Full understanding.

Secondary

MeasureTime frameDescription
Questionnaire Score Secondary Endpoint 1Change from 1 week prior to donation and 3 months after donationUnderstanding 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 2Change from 1 week prior to donation and 3 months after donationUnderstanding 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 3Change from 1 week prior to donation and 3 months after donationUnderstanding 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 4Change from 1 week prior to donation and 3 months after donationUnderstanding 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026