Expired Study
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Durham, North Carolina 27701


Purpose:

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 behalves; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.


Study summary:

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' behalves.


Criteria:

For potential kidney transplant recipients (all arms): Inclusion Criteria: - Adult (18 yrs or older) - African American - Duke Kidney and Pancreas Transplant patients with end stage kidney disease - Currently on the deceased donor kidney waiting list from the Duke Kidney and Pancreas Transplant Program - Give consent to participate Exclusion Criteria: - Previous kidney transplant - Cognitively impaired/Change in cognition - Impaired hearing or speech - Non-English speaking For family members or friends of potential kidney transplant recipients (TALK and TALK PLUS arms): Inclusion Critera: - 18 or older - Come to SWI meeting with patient - Give consent to participate For potential live kidney donors (TALKS PLUS arm only) Inclusion Criteria: - 18 or older - Contact the study - Give consent to participate


NCT ID:

NCT02369354


Primary Contact:

Principal Investigator
Leigh E Boulware, MD, MPH
Duke University


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27701
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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