A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Rodrigue, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00785265
First received: November 3, 2008
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

The main purpose of this study is to learn which educational method is most helpful to patients and their family members when they consider whether to pursue live donor kidney transplantation.

Patients who are eligible for a kidney transplant usually get information in the transplant clinic about two types of kidney transplants - one where the kidney comes from a dead donor and one where the kidney comes from a healthy living donor. Patients are given this information by a transplant nurse or doctor and then encouraged to discuss it with family members and friends.

In this study, we are trying to see if changing how and where we give patients this information makes a difference in how patients and their family members think about live donor kidney transplantation. So, we are looking at whether getting the information in the transplant clinic - either alone or in a group - is the same or different than getting the same information in your home.

The study is only recruiting African American patients. This is being done because African Americans have a higher likelihood of developing chronic kidney disease and needing a kidney transplant than patients of other races. However, they wait longer for a kidney transplant and die at a higher rate on the waiting list because they are less likely than other patients to receive a live donor kidney transplant. We want to see which educational approach works best with African American patients and their families.


Condition Intervention
Chronic Kidney Disease
End-stage Renal Disease
Behavioral: Group-Based (GB) Intervention
Behavioral: Home-Based (HB) Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Higher proportion of enrolled patients with live donor inquiries and evaluations; and higher number of potential donors educated. Improvement in live donation knowledge, concerns, and willingness to initiate live donor discussion with others. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: August 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Based
60-minute group session involving other study patients who have been assigned to this condition and their guests.
Behavioral: Group-Based (GB) Intervention
60-minute group session involving other study patients who have been assigned to this condition and their guests.
Active Comparator: Home-Based
60-minute educational intervention in their home, which will be delivered by an African American health educator.
Behavioral: Home-Based (HB) Intervention
60-minute educational intervention in their home, which will be delivered by an African American health educator.
No Intervention: Standard Care
60-minute individual session with an African American health educator.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American race
  • male or female
  • 21 to 80 years old
  • diagnosis of ESRD
  • eligible for listing on the kidney transplant waiting list at Beth Israel Deaconess Medical Center
  • resides within 150 minutes of transplant center
  • residential or cell phone service
  • signed informed consent

Exclusion Criteria:

  • Wait-listed for additional organ transplant (i.e., heart, liver)
  • current substance abuse or dependency
  • known or suspected psychotic disorder
  • known or suspected mental retardation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785265

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: James R Rodrigue, Ph.D. Beth Israel Deaconess Medical Center
Study Chair: Martha Pavlakis, MD Beth Israel Deaconess Medical Center
Study Chair: Didier Mandelbrot, MD Beth Israel Deaconess Medical Center
Study Chair: Ogo Egbuna, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Rodrigue, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00785265     History of Changes
Other Study ID Numbers: 2007P-000223, R01DK079665
Study First Received: November 3, 2008
Last Updated: December 18, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Live Donor Kidney Transplantation
LDKT
African Americans
Disparity
Education

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 16, 2014