Increasing Kidney Transplant Among Blacks on the Transplant Waiting List
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Change in readiness to pursue LDKT at 9 months
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-reported as Black or African-American
- •21 years of age or older
- •active on kidney transplant waiting list at Saint Barnabas Medical Center
排除标准
- •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
结局指标
主要结局
Change in readiness to pursue LDKT at 9 months
时间窗: Baseline, 9 months
Our primary outcome is the proportion of study participants with an increase in their readiness to pursue LDKT. Readiness to pursue LDKT is assessed by the patient's Stage of Change regarding pursuing live donation, based upon James Prochaska's Transtheoretical Model. The Stages of Change regarding pursuit of living donation include: not considering (Pre-contemplation), considering (Contemplation), preparing to pursue (Preparation), or taking action to pursue (Action) living donation within the next 6 months. Stage of Change will be assessed at baseline and at 9 months post-baseline.
次要结局
- Receipt of a LDKT(18 months)
- Status on kidney transplant waiting list(18 months)
- Change in knowledge of LDKT at 9 months(Baseline, 9 months)
- Number of donor volunteers recruited and evaluated(18 months)