Chronic Kidney Disease Clinical Trial
Official title:
Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
For most patients with kidney failure, living donor kidney transplant (LDKT) is their best treatment option. Unfortunately, Blacks (vs. non-Blacks) are more likely to have kidney failure but less likely to receive LDKTs. In this study, the investigators will test an intervention designed to address this disparity, by performing a parallel group, two-arm randomized clinical trial among 500 Black kidney transplant candidates. The main objective of this study is to test an educational and behavioral intervention that is designed to increase receipt of LDKT among transplant candidates (persons active on the deceased donor kidney transplant waiting list) who are Black. Our overall hypothesis is that a multi-component intervention administered to Black transplant candidates will increase both readiness to pursue LDKT and actual receipt of LDKTs. The investigators will randomly assign kidney transplant candidates on the kidney transplant waiting list to either: (1) a control group that will receive Usual Care, or (2) an Intervention group that will receive a group-based intervention, as well as monthly mailings and a follow-up phone call by a transplant educator.
The best treatment for severe chronic kidney disease is usually a living donor kidney
transplant (LDKT), but large racial disparities persist in receipt of LDKTs. In 2011, Blacks,
who comprised 36.8% of the dialysis population, received 32.2% of deceased donor kidney
transplants (DDKTs) but just 14.0% of LDKTs. Among kidney transplant candidates who are
Black, their lower rate of LDKT largely stems from a lack of donor volunteers (persons
interested in donating a living kidney to them). The most effective ways to motivate and help
Black transplant candidates to "recruit" or identify any (or more) donor volunteers remain
unclear. Several interventions appear promising and are being tested, but none has proven
both practical and effective.
Transplant candidates, particularly those who are Black, report that multiple barriers
prevent them from receiving LDKTs. These barriers include minimal knowledge about LDKT; fears
about donors' future health; guilt; medical mistrust; and discomfort about how to discuss
LDKT with family and friends. Most transplant candidates have never met either a kidney donor
or a recipient of a transplant or LDKT. A multi-component intervention that efficiently
addresses these barriers could plausibly increase receipt of LDKT among Blacks.
The main objective of this study is to test an educational and behavioral intervention that
is designed to increase receipt of LDKT among transplant candidates (persons active on the
DDKT waiting list) who are Black. Our overall hypothesis is that a multi-component
intervention administered to Black transplant candidates will increase both readiness to
pursue LDKT and actual receipt of LDKTs.
To meet this objective and test our hypothesis, we propose a two-arm, parallel group
randomized trial among 500 Black kidney transplant candidates. After Black transplant
candidates are placed on the waiting list for a DDKT, we will randomize them to either: (1) a
control group that will receive Usual Care, or (2) an Intervention group that will receive a
group-based intervention as well as monthly mailings and a follow-up phone call by a
transplant educator. Participants randomized to the Intervention will be asked to attend, in
small groups with any family and friends, a 60-90 minute seminar that will feature brief
talks regarding: ●basic facts about CKD, transplant, and the waiting list; ●the experience of
receiving a LDKT transplant (by a Black LDKT recipient); ●the experience of serving as a
living kidney donor (by a Black living kidney donor); and ●strategies to increase the chances
of getting a transplant sooner.
Our Specific Aims are as follows:
Aim 1 (Primary Aim): To compare readiness to pursue LDKT and receipt of LDKT in the
Intervention vs. Usual Care groups of our randomized clinical trial, during the 18 months
after randomization
Hypothesis: Exposure to the multi-component Intervention is associated with an increase in
readiness to pursue LDKT and an increase in receipt of LDKT
Aim 2: To determine the baseline social and behavioral variables that modify the effect of
the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Greater knowledge of LDKT and greater readiness to pursue LDKT are associated
with receipt of LDKT
Aim 3: To determine whether changes in social and behavioral variables mediate the effects of
the Intervention upon readiness to pursue LDKT and actual receipt of LDKT
Hypothesis: Increases in readiness to pursue LDKT are associated with receipt of LDKT
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