RELIVE Informed Consent Study

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

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.

Study Overview

• Status: Completed
• Conditions: Living Donors; Tissue Donors
• Intervention / Treatment: Procedure: Organ Donation

• Study Type: Observational
• Enrollment (Actual): 624

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Living donor of a kidney or lung

Exclusion Criteria:

• Unable to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Maryam Valapour, MD, University of Minnesota, Center for Bioethics

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DAIT RELIVE 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: SDY292
   Information comments: ImmPort study identifier is SDY292
2. Study Protocol
   Information identifier: SDY292
   Information comments: ImmPort study identifier is SDY292. The study protocol is available in the Design tab section.