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Transplant Social Worker Support for Live Kidney Donation in African Americans (TALKS)

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ClinicalTrials.gov Identifier: NCT02369354
Recruitment Status : Recruiting
First Posted : February 23, 2015
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Kidney Disease Behavioral: TALKS Social Worker Intervention Other: Financial Assistance Intervention Not Applicable

Detailed 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' behalves.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Transplant Social Worker Support for Live Kidney Donation in African Americans
Actual Study Start Date : September 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Usual Care
Usual medical care at the Duke Kidney Transplant Clinic
TALKS
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings
Behavioral: TALKS Social Worker Intervention
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.
TALKS PLUS
Usual Care plus TALKS Social Worker Intervention: Includes video, book, and Social Worker meetings plus live donor financial assistance intervention
Behavioral: TALKS Social Worker Intervention
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.
Other: Financial Assistance Intervention
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.



Primary Outcome Measures :
  1. Live kidney donor activation [ Time Frame: 1 year ]
    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


Secondary Outcome Measures :
  1. Potential recipient interest and pursuit of live donor kidney transplantation [ Time Frame: 1 year ]
    Potential kidney recipients' behaviors reflecting their interest and pursuit of live donor kidney transplantation, including: self-reported live donor kidney transplant discussions with physicians, self-reported live donor kidney transplant discussions with family, and identification of a potential live donor.

  2. Live kidney donor activation [ Time Frame: 2 years ]
    Passive follow up of participants for 2 years to assess 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369354


Contacts
Contact: Tara S Strigo, MPH 919-668-4536 tara.strigo@duke.edu
Contact: Iris A Pounds, MBA/MHA 919-668-7214 iris.pounds@duke.edu

Locations
United States, North Carolina
Duke School of Medicine, Division of General Internal Medicine Recruiting
Durham, North Carolina, United States, 27701
Contact: Tara S Strigo, MPH    919-668-4536    tara.strigo@duke.edu   
Contact: Iris A Pounds, MBA/MHA    919-668-7214    iris.pounds@duke.edu   
Principal Investigator: Leigh E Boulware, MD, MPH         
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Leigh E Boulware, MD, MPH Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02369354     History of Changes
Other Study ID Numbers: Pro00052724
1R01DK098759 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Duke University:
Kidney Transplant
African Americans

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases