A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| 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 |
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 May 22, 2013