Transplant Social Worker Support for Live Kidney Donation in African Americans
TALKS
2 other identifiers
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2019
CompletedResults Posted
Study results publicly available
July 5, 2023
CompletedJuly 5, 2023
June 1, 2023
3.8 years
February 17, 2015
March 24, 2023
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Live Kidney Donor Activation Events
Composite rate of live kidney donor inquiries on behalf of participants, completed live kidney donor transplant evaluations, and live kidney donor transplants in each arm, ascertained via medical records maintained by the Duke Kidney and Pancreas Transplant Program.
24 months post randomization
Secondary Outcomes (3)
Number of Participants With Potential Recipient Interest and Pursuit of Live Donor Kidney Transplantation
24 months post randomization
Number of Participants With Live Donor Evaluations
24 months post randomization
Number of Participants With Live Kidney Donor Transplants
24 months post randomization
Study Arms (3)
Usual Care
NO INTERVENTIONUsual medical care at the Duke Kidney Transplant Clinic
TALKS
OTHERUsual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
TALKS PLUS
OTHERUsual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
Interventions
TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
The financial assistance intervention offers potential donors the ability to draw from a "bank" of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous kidney transplant (Revised Sept 2016: persons who have previously received a deceased donor kidney transplant, but who have not previously received a live donor 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):
- or older
- Come to SWI meeting with patient
- Give consent to participate
- For potential live kidney donors (TALKS PLUS arm only)
- or older
- Contact the study
- Give consent to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke School of Medicine, Division of General Internal Medicine
Durham, North Carolina, 27701, United States
Related Publications (2)
Boulware LE, Sudan DL, Strigo TS, Ephraim PL, Davenport CA, Pendergast JF, Pounds I, Riley JA, Falkovic M, Alkon A, Hill-Briggs F, Cabacungan AN, Barrett TM, Mohottige D, McElroy L, Diamantidis CJ, Ellis MJ. Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial. Am J Transplant. 2021 Jun;21(6):2175-2187. doi: 10.1111/ajt.16403. Epub 2021 Jan 4.
PMID: 33210831DERIVEDStrigo TS, Ephraim PL, Pounds I, Hill-Briggs F, Darrell L, Ellis M, Sudan D, Rabb H, Segev D, Wang NY, Kaiser M, Falkovic M, Lebov JF, Boulware LE. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial. BMC Nephrol. 2015 Oct 9;16:160. doi: 10.1186/s12882-015-0153-y.
PMID: 26452366DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was performed at a single transplant center, which may limit generalizability of results. The study's follow-up time may not have been sufficient for participants to identify new potential donors, initiate discussions, and for potential donors to become activated toward living kidney donation. Additionally, participants with longer wait-list times may have been less motivated to pursue LDKT. Lastly, we did not assess reasons for non-use of the TALKS financial assistance.
Results Point of Contact
- Title
- Dr. L. Ebony Boulware
- Organization
- Duke University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Leigh E Boulware, MD, MPH
Duke University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
February 23, 2015
Study Start
September 1, 2015
Primary Completion
July 2, 2019
Study Completion
July 2, 2019
Last Updated
July 5, 2023
Results First Posted
July 5, 2023
Record last verified: 2023-06