Computer Education to Increase Living Kidney Donation AFRICAN-AMERICANS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01553864
First received: March 12, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

Kidney transplantation offers patients in end-stage renal disease (ESRD) 3 to 17 additional years of life and improved quality-of-life compared to remaining on dialysis. Because of the deceased donor organ shortage, more kidney patients are choosing to receive kidneys from family and friends, a process called living donor kidney transplantation (LDKT). Although African-Americans are 3.7 times more likely to develop ESRD, they are less likely to receive LDKTs. Therefore, this project will assess whether racial disparities in transplant knowledge, readiness to pursue LDKT, completion of transplant medical evaluation, and receipt of LDKTs can be reduced when ESRD patients receive access to personalized coaching and individually-tailored feedback using an Explore Transplant computerized Expert System. This multilevel study will also examine how other known patient, family, and healthcare system barriers to LDKT impact the Expert System's effectiveness. ESRD patients presenting for transplant medical evaluation at Barnes-Jewish Transplant Center in St. Louis, Missouri (465 African-Americans, 465 Whites) will be stratified by race and randomized to one of two education conditions (Explore Transplant Expert System vs. Standard Education Control). As they complete transplant medical evaluation, patients in the Expert System condition will receive individually tailored feedback reports and personalized coaching addressing variables important to behavior change and associated with LDKT health disparities. Control patients will only receive standard-of-care education provided by the transplant center. Changes in key outcomes will be assessed at four time points (2-months before in-hospital evaluation day (IHED) (baseline), 2- and 6-months post-IHED, and 18-months post-baseline). The grant has four aims:

Aim 1 (Primary): Compared to the Control Group, to determine whether African-American and White patients receiving the Expert System increase in their LDKT readiness and transplant knowledge 6-months post-IHED.

Aim 2: Compared to the Control group, to determine whether African-American and White patients receiving the Expert System are more likely to complete transplant medical evaluation and pursue LDKT 18-months post-baseline.

Aim 3: To examine whether the Expert System's effectiveness in changing LDKT decision-making and behavior is equivalent between African-Americans and Whites.

Aim 4: To examine how known patient, family, and healthcare system barriers to LDKT act alone and in combination with the Expert System to affect African-Americans' decision-making and behavior.

At the conclusion of the study, we will have developed an innovative and cost-effective Explore Transplant Expert System that could be utilized by providers in 5,000 dialysis and 250 transplant centers to tailor LDKT discussion and education based on the needs of individual patients of different races.


Condition
Kidney Transplant Attitudes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Tailored Computer Education to Increase Living Donation in African-Americans

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Estimated Enrollment: 250
Study Start Date: January 2012
Estimated Study Completion Date: April 2012
  Eligibility

Ages Eligible for Study:   18 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population is African-American and White patients 18 years of age and older, since BJTC does not transplant patients under 18 years of age. To be eligible for the RCT, patients must: 1) have completed their medical forms and have been scheduled for IHED; 2) speak English; 3) have a working telephone number; and 4) have not have had a previous kidney transplant.

Criteria

Inclusion Criteria:

  • Are eligible for a kidney transplant

Exclusion Criteria:

  • Have not had a kidney transplant
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553864

Contacts
Contact: Amy Waterman, PhD (314) 454-8102 awaterma@wustl.edu

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Gene Ridolfi    314-362-0885    ger2342@bjc.org   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Amy Waterman, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01553864     History of Changes
Other Study ID Numbers: 201109300
Study First Received: March 12, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2014