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OpenTrials
Completed

NCT Number: NCT01742234

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.

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Key information

Conditions

Living Donors Tissue Donors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Living donor of a kidney or lung

Exclusion criteria

  • Unable to give informed consent

Treatment and study plan

Organ Donation

Procedure

People in this study will donate either a lung or kidney

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2012
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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