Clinical trial NCT02319447: Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
Official title: Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
End-Stage Renal Disease
Keywords: Living Donation
Kidney Transplantation
Lead sponsor: St. Barnabas Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Rutgers University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-12-18
Enrollment: 223
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* self-reported as Black or African-American
* 21 years of age or older
* active on kidney transplant waiting list at Saint Barnabas Medical Center

Exclusion Criteria:

* limited English proficiency
* unable or unwilling to provide informed consent
* unable to complete in-person and telephone questionnaires (including hearing impairment or low vision)
* lack a working telephone
* live 150 miles or greater from transplant center
* enrolled in prior randomized intervention trial, NCT01261910, at our center
* currently already scheduled to receive a live donor kidney transplant
* active on the simultaneous pancreas-kidney transplant waiting list

Primary outcomes:
measure: Change in readiness to pursue LDKT at 9 months
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Receipt of a LDKT
timeFrame: 18 months
measure: Number of donor volunteers recruited and evaluated
timeFrame: 18 months
measure: Status on kidney transplant waiting list
timeFrame: 18 months
measure: Change in knowledge of LDKT at 9 months
timeFrame: Baseline, 9 months
Other outcomes:
measure: Change in knowledge of LDKT at 1 week post-intervention
timeFrame: Baseline, 1 week post-intervention
measure: Change in readiness to pursue LDKT at 1 week post-intervention
timeFrame: Baseline, 1 week post-intervention
Locations:
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
Study officials:
affiliation: St. Barnabas Medical Center
name: Francis L Weng, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: