PatientsVille.com LogoPatientsVille.com

End-stage Kidney Disease | Optimizing Kidney Transplant Informed Consent

End-stage Kidney Disease research study

What is the primary objective of this study?

The objective of this study is to evaluate kidney transplant candidates' comprehension about increased risk donor kidneys necessary for informed consent. We have developed a web-based tool that educates and assesses candidates' comprehension (Inform Me), as a supplement to current informed consent processes. We will then compare the effectiveness of the current informed consent processes supplemented by Inform Me, with the current consent processes alone for kidney transplant.

Who is eligible to participate?

Inclusion Criteria: - English-speaking - 21 years or older - Kidney Transplant candidates eligible: 1) completed the first phase of transplant evaluation education, and 2) wait-listed patients expected to receive a transplant within the next 6 months, returning for re-evaluation. Exclusion Criteria: - No special classes of study participants, including fetuses, neonates, prisoners, institutionalized individuals, or other vulnerable populations will be included in the proposed study. Although pregnant women will be eligible for participation in the study, they are unlikely to be selected for kidney transplantation.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

End-stage Kidney Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Inform Me: web-based education toolThe purpose of Inform Me is to help kidney transplant candidates understand what kidneys from increased risk donors are and describes the risks and benefits of accepting and refusing a kidney from an increased risk donor. Increased risk donors are donors who engaged in behaviors that increase their chances of having: Human Immunodeficiency Virus, Hepatitis B Virus , Hepatitis C Virus. Inform Me focuses only on increased risk donor kidneys. Inform Me aims to prepare patients to make a decision with their transplant team to accept or to refuse a kidney from an increased risk donor. Inform Me does not try to convince patients to accept or refuse a kidney from increased risk donors.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Inform Me: web-based education toolIntervention will receive the standard of care, the Inform Me intervention, a post-test evaluation, and 1 week recall test.

Control Standard of CareThis group receives standard of care with a post test.

Study Status

Completed

Start Date: October 2013

Completed Date: November 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Knowledge of increased risk donor kidney transplants

Secondary Outcome: Willingness to accept an increased risk donor kidney transplant

Study sponsors, principal investigator, and references

Principal Investigator: Elisa Gordon, PhD, MPH

Lead Sponsor: Northwestern University

Collaborator: University of Alabama at Birmingham

More information:https://clinicaltrials.gov/show/NCT01859884

Discuss Increased