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临床试验/NCT01439516
NCT01439516已完成不适用

Information and Financial Interventions for Kidney Donation in African Americans

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2012年8月最近更新:
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
92
试验地点
2
主要终点
Pursuit of Living Related Transplantation

研究概览

简要总结

African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. waiting lists and immunological incompatibility), but minorities are less likely to receive living related kidney transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or physicians at optimal rates, and thus may not have adequate information to initiate or participate in shared decision-making regarding LD/LRT. African Americans may also have financial concerns regarding convalescence and out of pocket expenses related to LD/LRT, another barrier impeding LD/LRT.

The primary goals of this study are to overcome these important barriers by enhancing ethnic minorities' consideration of LD/LRT through the promotion of shared decision-making regarding LD/LRT and provision of financial assistance for out of pocket expenses. The investigators specific aims are: a) to develop culturally sensitive informational (audiovisual) and financial interventions and b) to perform a randomized controlled trial to assess their effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and their families. The investigators hypothesize: (1) Patients and families who view informational materials designed to promote shared decision-making regarding LD/LRT will be more likely than patients and families not viewing these materials to discuss LD/LRT with family and with health care professionals. Patients and families viewing such informational materials will also be more likely than those not viewing these materials to pursue and complete the LD/LRT process and (2) patients and their families who are offered the intervention to promote shared decision-making plus a financial assistance intervention for potential live kidney donors will be more likely than patients and families not offered both interventions to pursue and complete the LD/LRT process.

详细描述

The investigators will enroll 210 adult African American patients with new-onset ESRD from dialysis facilities in the Baltimore metropolitan area and measure their initial commitment to pursue LD/LRT. Participants will then be randomized to one of three groups: 1) informational intervention alone (PREPARED education), 2) informational intervention plus living donor financial assistance program (PREPARED plus financial assistance), and 3) no intervention (Usual Care). The investigators will follow participants for up to 6 months for progression in their commitment to LD/LRT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years
  • Self-reported as African-American
  • English Speaking

排除标准

  • Prior Kidney Transplant
  • Non-English Speaking
  • Cancer within 2 years prior to recruitment date
  • Stage 4 Congestive Heart Failure
  • End Stage Liver Disease
  • Unstable Coronary Artery Disease
  • Pulmonary Hypertension
  • Severe Peripheral Vascular Disease
  • Chronic Debilitating Infections

研究组 & 干预措施

Information

Experimental

Participants randomized to this arm of the study will received the PREPARED educational book and video.

干预措施: Information (Behavioral)

Information and Financial Assistance

Experimental

Participants randomized to this arm of the study will receive the PREPARED educational book and video plus financial assistance for family members to cover costs associated with an evaluation for becoming a live kidney donor.

干预措施: Information (Behavioral)

Usual Care

No Intervention

Participants randomized to this arm of the study will receive usual care from their physician.

结局指标

主要结局

Pursuit of Living Related Transplantation

时间窗: 6 months

Measurement of patients' pursuit of LRT will be performed using a series of questions that assess the participants' knowledge, interest, and perceived barriers to LRT. We will also ascertain use of the living donor financial assistance among potential donors and completion of evaluation and kidney transplant among both patient participants and potential living donors.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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