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临床试验/NCT03354910
NCT03354910已完成不适用

Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Disparities in Live Donor Kidney Transplantation

Beth Israel Deaconess Medical Center4 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2018年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
4
主要终点
Live donor kidney transplants

研究概览

简要总结

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.

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
Double (Investigator, 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

入选标准

  • Black race (including possible Cape Verdean, Haitian, Dominican)
  • ≥18 yrs old
  • English speaking
  • Meets eligibility criteria for kidney transplant evaluation
  • Ability to provide informed consent
  • Resides within 1.5 hr drive of HC educator

排除标准

  • Temporarily Unavailable (TU) on the waiting list and TU is likely to exceed 6 months based on judgement of kidney transplant team
  • Awaiting combined kidney-liver transplantation
  • Awaiting simultaneous pancreas-kidney transplantation
  • Participation in another study to increase the likelihood of LDKT
  • Prior participation in a transplant HC
  • Prior or current participation in the NKF PM program

研究组 & 干预措施

Usual Care

No Intervention

All enrolled patients will receive Usual Care for transplant candidates at our two centers, which includes individual meetings with transplant providers, attendance at a patient group education session in the transplant center (focused on the specifics of the transplant experience), and a transplant education binder.

UC + HC + Peer Mentorship

Experimental

Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call.

干预措施: House Call (Behavioral)

Usual Care (UC) + House Calls (HC)

Active Comparator

Patients and their invited guests will be scheduled for one House Call. A house call is meeting done at a patient's home with transplant health educators facilitating a discussion on topics related to living kidney donation. Patients and guests also receive an information packet containing several brochures providing information about the living donation process, common concerns and misperceptions, and donation resources and information about our transplant center (e.g., copy of our quarterly newsletter, contact information). Patients in the group will also receive Usual Care, the regular education on living donation, provided as part of their routine transplant care.

干预措施: House Call (Behavioral)

UC + HC + Peer Mentorship

Experimental

Patients in this condition will receive the Usual Care and the House Calls intervention as described previously. In addition, participants will receive access to a Peer Mentor trained by the National Kidney Foundation following their House Call.

干预措施: Peer Mentorship (Behavioral)

结局指标

主要结局

Live donor kidney transplants

时间窗: 1 Year Post-Intervention

The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants after 1 year.

次要结局

  • Live donor evaluations(1 Year Post-Intervention)
  • Live donor inquiries(1 Year Post-Intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Rodrigue

Professor of Psychology in the Department of Psychiatry

Beth Israel Deaconess Medical Center

研究点 (4)

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