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RELIVE Informed Consent Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742234
First Posted: December 5, 2012
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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: Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study

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

Primary Outcome Measures:
  • Questionnaire Score 1 [ Time Frame: 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 [ Time Frame: 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."

  • Questionnaire Score 3 [ Time Frame: 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."


Secondary Outcome Measures:
  • Questionnaire Score Secondary Endpoint 1 [ Time Frame: 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 2 [ Time Frame: 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 3 [ Time Frame: 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 4 [ Time Frame: 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."


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SDY292
ImmPort study identifier is SDY292
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SDY292
ImmPort study identifier is SDY292. The study protocol is available in the Design tab section.

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01742234     History of Changes
Other Study ID Numbers: DAIT RELIVE 03
First Submitted: November 28, 2012
First Posted: December 5, 2012
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.