Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02369354 |
| Other study ID # |
Pro00052724 |
| Secondary ID |
1R01DK098759 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
July 2, 2019 |
Study information
| Verified date |
June 2023 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education,
behavior, and financial support interventions to improve consideration of live kidney
transplantation/live kidney donation among African Americans on the deceased kidney waiting
list. We hypothesize that interventions to help potential kidney transplant recipients and
their potential donors overcome barriers to live donor kidney transplant (including family
discussions, financial, or logistical barriers) could improve potential recipients' receipt
of live kidney transplants. The main outcomes of TALKS will include whether potential
recipients (1) have potential live donors call into the transplant center on their behalf;
(2) have potential donors evaluated for transplant; or (3) receive a live donor kidney
transplant.
Description:
Live donor kidney transplantation (LDKT) represents an optimal therapy for many patients.
However, African Americans have been persistently and significantly less likely to receive
LDKT when compared to Whites. The process of seeking and establishing a live donor for LDKT
requires potential donors overcome several potential obstacles to LKDT. As a critical first
step to seeking LDKT, patients must engage their physicians and their family members or
friends (who provide support for patients' health decisions and could also be potential
donors) in discussions about LDKT to determine whether LDKT is a viable and/or desirable
treatment option. LDKT discussions with physicians help patients and family members
understand the risks and benefits of LDKT to both the potential recipient and any potential
donors. Families' LDKT discussions help them establish whether it is possible to identify
willing and medically eligible live donors, and they help families discuss the potential
psychological, physical, and financial strains of LDKT on patients and families. Once
discussions have occurred, potential donors must confront logistical (e.g., childcare or
travel to transplant centers) and financial (e.g., unpaid time away from work) challenges
associated with LDKT. Studies have shown that even when African American patients desire
LDKT, rates of LDKT discussions are suboptimal. Further, African American potential live
kidney donors are less likely than their White counterparts to complete the donor evaluation
process, and they may be more sensitive than Whites to logistical and financial barriers to
LDKT. Innovative strategies to overcome interpersonal, logistical and financial barriers to
LDKT are sorely needed for African Americans, particularly those who may be highly motivated
to seek this therapy. Transplant social workers routinely perform psychosocial evaluations on
potential LDKT recipients and donors and are well suited to support families' navigation of
LDKT discussions. Transplant social workers are also well versed in the financial aspects of
LDKT (e.g., insurance coverage rules) and frequently provide financial guidance to potential
LDKT recipients and donors. We will study innovative transplant social worker led
interventions designed to help African American potential LDKT recipients and their families
overcome interpersonal, logistical and financial barriers to LDKT. African Americans on the
deceased kidney donor waiting list will be randomly assigned to (1) receive their usual care
on the transplant list or (2) to one of two social worker led interventions-one which helps
patients and families discuss LDKT with each other and with patients' physicians, and one
which provides families with financial support to overcome logistical and financial barriers
to LDKT. As a primary outcome, we will measure whether the interventions activate live kidney
donation on African American potential recipients' behalf.
