Clinical trial NCT03819686: Reducing Disparities in Living Donor Transplant Among African Americans
Official title: Reducing Disparities in Living Donor Transplant Among African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: end stage renal disease
ESRD
living donor kidney transplantation
LDKT
African American
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-01-28
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Patients With at Least One Inquiry From a Potential Living Donor
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Knowledge and Understanding of Donation/Transplantation Assessment Score
timeFrame: Baseline, Day 1 immediately post-intervention
measure: Motivation Scale Score to Ask a Family Member to be a Living Donor
timeFrame: Baseline, Day 1 immediately post-intervention
measure: Confidence in Initiating a Conversation About LDKT
timeFrame: Baseline, Day 1 immediately post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Transplant Center
state: Georgia
Study officials:
affiliation: Emory University
name: Kimberly Jacob Arriola, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.