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RELIVE Informed Consent Study

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ClinicalTrials.gov Identifier: NCT01742234
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
Living Donors Tissue Donors Procedure: Organ Donation

Study Type : Observational
Actual Enrollment : 624 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study
Study Start Date : August 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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



Primary Outcome Measures :
  1. 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."

  2. 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."

  3. 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 :
  1. 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."

  2. 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."

  3. 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."

  4. 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."



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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

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

Additional Information:
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.

Publications of Results:
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 Posted: December 5, 2012    Key Record Dates
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.