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Optimizing Kidney Transplant Informed Consent

NCT01859884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2015-11-20

No results posted yet for this study

Summary

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.

Conditions

  • End-stage Kidney Disease

Interventions

BEHAVIORAL

Inform Me: web-based education tool

The 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.

Sponsors & Collaborators

Principal Investigators

  • Elisa Gordon, PhD, MPH · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859884 on ClinicalTrials.gov