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RELIVE Informed Consent Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01742234
First received: November 28, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Living Donors
Tissue Donors
 Procedure: Organ Donation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: RELIVE Informed Consent Study

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Questionare Score 1 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."

  • Questionare Score 2 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."

  • Questionare Score 3 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."


Secondary Outcome Measures:
  • Questionare Score Secondary Endpoint 1 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    Understanding of short-term medical risks of donation answered on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."

  • Questionare Score Secondary Endpoint 2 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    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."

  • Questionare Score Secondary Endpoint 3 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    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."

  • Questionare Score Secondary Endpoint 4 [ Time Frame: Change from 1 week prior to donation and 3 months after donation ] [ Designated as safety issue: No ]
    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."


Enrollment: 624
Study Start Date: August 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • living donor of a kidney or lung

Exclusion Criteria:

  • unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742234

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Maryam Valapour, MD University of Minnesota, Center for Bioethics
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01742234     History of Changes
Other Study ID Numbers: DAIT RELIVE 03
Study First Received: November 28, 2012
Last Updated: December 3, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on May 19, 2013