A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00785265 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 5, 2008
Last Update Posted
: September 12, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease End-stage Renal Disease | Behavioral: Group-Based (GB) Intervention Behavioral: Home-Based (HB) Intervention | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Health Services Research |
Official Title: | A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation |
Study Start Date : | August 2007 |
Actual Primary Completion Date : | November 2015 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
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.
|
- The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. [ Time Frame: one year ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785265
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
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 |
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: |
2007P000223 R01DK079665 ( U.S. NIH Grant/Contract ) |
First Posted: | November 5, 2008 Key Record Dates |
Last Update Posted: | September 12, 2017 |
Last Verified: | September 2017 |
Keywords provided by James Rodrigue, Beth Israel Deaconess Medical Center:
Live Donor Kidney Transplantation LDKT African Americans Disparity Education |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |