Reducing Disparities in Living Donor Transplant Among African Americans

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment, and living donor kidney transplantation (LDKT) is preferable. Nevertheless, there are pervasive racial disparities in access to LDKT. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over study period.The long-term objective is to understand the combined effect of a systems-level intervention (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant
• Intervention / Treatment: Behavioral: Living ACTS website; Behavioral: Standard transplant education procedures

Detailed Description

For most of the patients in the United States with end stage renal disease (ESRD), kidney transplantation represents the optimal treatment. Moreover, living donor kidney transplantation (LDKT) offers numerous advantages such as better kidney quality, increased short- and long-term graft survival, lower rates of acute rejection, and reduced health care cost. Nevertheless, there are pervasive racial disparities in access to LDKT, with white ESRD patients four times more likely to receive a LDKT than African American ESRD patients. The main outcome of this study is change in the proportion of study participants who have at least one living donor inquiry by friends/family over 12 months from baseline.The long-term objective is to understand the combined effect of a systems-level intervention that enhances communication between dialysis facility and transplant center clinicians (Transplant Referral EXchange or T-REX) and a culturally-sensitive individual-level educational intervention (web-based Living ACTS: About Choices in Transplantation and Sharing) on racial disparities in access to LDKT.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Transplant Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients referred (from dialysis facility, chronic kidney disease clinic, or self) and scheduled for an evaluation at one of the four study sites within the study time period.
• African American or Black
• age 18 to 70 years
• BMI < 39
• English-speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Living ACTS website; In addition to the provision of standard transplant education procedures, a patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching the 20-minute video).	Behavioral: Living ACTS website; Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching ~20-minutes of videos from the website); Behavioral: Standard transplant education procedures; Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
Other: Standard transplant education procedures; Usual Care, which involves the provision of standard transplant education procedures at each transplant center, which entail reviewing a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two 10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.	Behavioral: Standard transplant education procedures; Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients With at Least One Inquiry From a Potential Living Donor	Data collection form that captures potential recipient ID (i.e. study participant), date of living donor inquiry, and donor inquiry ID, will be securely obtained from each transplant center following a 12 month period from enrollment. Data will be collected electronically for all study participants through a secure, HIPAA-compliant data server (QualityNet). The percent of patients with at least one inquiry from a potential living donor among patients who receive Living ACTS will be compared to those who receive a control website with embedded educational video.	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and Understanding of Donation/Transplantation Assessment Score	Scale includes 13 true/False questions, score ranges from 0 to 13, 0 Min-13 Maximum where higher scores indicate greater knowledge (i.e., participants receive 1 point for each correct answer).	Baseline, Day 1 immediately post-intervention
Motivation Scale Score to Ask a Family Member to be a Living Donor	9-item scale assesses motivation to ask a family member to be a living donor. Potential responses range from 1 to 5, Possible score range from 9 to 45 with higher values indicating stronger agreement with the statement.	Baseline, Day 1 immediately post-intervention
Confidence in Initiating a Conversation About LDKT	10-item behavioral skills scale measures confidence in initiating a conversation about LDKT. Potential responses range from 1 to 5, total possible score range is 10-50, with higher values indicate stronger confidence.	Baseline, Day 1 immediately post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive and final list of website modifications.	A series of individual interviews with participants will be conducted to obtain feedback on the web-based version of Living ACTS. All facilitators will meet to compare findings and to compose a comprehensive and final list of website modifications. Participant feedback will be used to refine and finalize the web-based intervention.	12 months post-baseline
Change in intention to discuss LDKT with family members	1-item behavioral intentions scale measures intention to discuss LDKT with family members, score ranges 1-5 (1-extremely unlikely, 5 - extremely likely)	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Kimberly Jacob Arriola, PhD, MPH, Emory University

Publications and helpful links

General Publications

• Arriola KJ, Barrett D, Pastan S, Perryman J, DuBay D, Tresslar C, De Abreu SU, Di M, Teunis L, Montoya M, Mangurenje T, Patzer RE. Immediate Postintervention Outcomes from a Randomized Trial that Sought to Enhance Access to Live Donor Kidney Transplant for Black and African Americans. Prog Transplant. 2025 Mar;35(1):5-12. doi: 10.1177/15269248241304794. Epub 2024 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2019
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: ESRD; African American; end stage renal disease; LDKT; living donor kidney transplantation
• Other Study ID Numbers: IRB00098952; R01DK114891 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No