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| Sponsor: | Beth Israel Deaconess Medical Center |
|---|---|
| Collaborator: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Information provided by (Responsible Party): | James Rodrigue, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00785265 |
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 |
| Estimated Enrollment: | 180 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (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:
Exclusion Criteria:
Contacts and Locations| Contact: James R Rodrigue, Ph.D. | 617-632-9700 | jrrodrig@bidmc.harvard.edu |
| Contact: Martha Pavlakis, MD | 617-632-9700 | mpavlaki@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: James R Rodrigue, Ph.D. 617-632-9700 jrrodrig@bidmc.harvard.edu | |
| Principal Investigator: Martha Pavlakis, MD | |
| Sub-Investigator: Didier Mandelbrot, MD | |
| Sub-Investigator: Ogo Egbuna, MD | |
| 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
| 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: | January 5, 2012 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
Live Donor Kidney Transplantation LDKT African Americans Disparity Education |
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |