RELIVE Informed Consent Study

NCT01742234 | Completed DMC

• 1 other identifier: DAIT RELIVE 03
• Study Type: observational
• Target: 624
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Living Donors; Tissue Donors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Questionnaire Score Secondary Endpoint 1

  Change from 1 week prior to donation and 3 months after donation

• Questionnaire Score Secondary Endpoint 2

  Change from 1 week prior to donation and 3 months after donation

• Questionnaire Score Secondary Endpoint 3

  Change from 1 week prior to donation and 3 months after donation

• Questionnaire Score Secondary Endpoint 4

  Change from 1 week prior to donation and 3 months after donation

Study Arms (2)

Kidney Donors

People who will donate a kidney at the University of Minnesota, Mayo Clinic, or University of Alabama

Procedure: Organ Donation

Lung Donors

People who will donate a lung at the Washington University School of Medicine or the University of Southern California

Procedure: Organ Donation

Interventions

Organ Donation PROCEDURE

People in this study will donate either a lung or kidney

Kidney Donors; Lung Donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Living donor of a kidney or lung

You may not qualify if:

• Unable to give informed consent

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related 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. Epub 2010 Dec 16.

  PMID: 21158924 RESULT

Related Links

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

MeSH Terms

Interventions

Tissue and Organ Procurement

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Maryam Valapour, MD

  University of Minnesota, Center for Bioethics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 5, 2012
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share