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临床试验/NCT03099434
NCT03099434进行中(未招募)不适用

Expanding Live Donor Kidney Transplantation Through Advocacy Training and Social Media

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 775 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
775
试验地点
2
主要终点
Live donor kidney transplantation

研究概览

简要总结

This pilot study will be a clinical trial to test the feasibility and effectiveness of an educational intervention and a mobile health intervention in adults with end stage renal disease (ESRD) who have not yet identified a potential live donor.

详细描述

Transplant candidates are hesitant to discuss their illness and the difficulties associated with dialysis, and are therefore reluctant to pursue live donor kidney transplant (LDKT). The investigators will conduct a prospective 3-arm randomized controlled trial with two novel interventions to increase live donation. Arm 1 includes LDC program and the Facebook app, Arm 2 includes just the Facebook app, and Arm 3 includes standard of care. The investigators primary objective is to demonstrate the the effectiveness of these interventions in increasing live donor transplantation rates for candidates with no prior potential live donor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Double (Care Provider, Investigator)

入排标准

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

入选标准

  • •Kidney transplant candidates aged≥18 added to the waitlist in the last year with no potential live donors are eligible.
  • •If there is an individual willing to donate, but the candidate is unwilling to consider this option or this particular individual, the candidate is eligible for the trial and may still benefit from identification of new donors or increased comfort accepting donation from others.
  • •Participants at Johns Hopkins University or University of Alabama must speak English. Participants at Northwestern University must speak English or Spanish.

排除标准

  • •Candidates with live donors currently under evaluation for donation will be excluded.
  • •Those with a previous kidney transplant will be excluded

研究组 & 干预措施

Live Donor Champion + Facebook App

Active Comparator

The LDC program consists of 6 monthly sessions of approx. 1 hour each. Each LDC session is led by a transplant physician or clinical coordinator. LDC sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LDC sessions are as follows: 1) education about ESRD, KT, and LDKT 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) encouraging candidate self-efficacy. At session 3, the the Facebook app will be incorporated and given to candidates. The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network.

干预措施: Live Donor Champion + Facebook App (Behavioral)

Facebook App

Active Comparator

The Facebook app provides step-by-step instructions for creating a Facebook post that details each waitlist candidate's struggle with ESRD and their need for a live donor. The post is then uploaded to Facebook so it can be shared with the candidate's Facebook social network. The Facebook App prompts users with specific questions to create a narrative. Links to supplemental resources are auto-populated into the post to provide anyone that views the post with vetted information about the risks, benefits, and process of live donation. Candidates using the Facebook app attend one focus group session held at the transplant center where they are provided with verbal instructions and visual demonstrations of installation and use of the Facebook app.

干预措施: Facebook App (Behavioral)

Standard of Care

No Intervention

Standard of Care does not include any of the interventions detailed above, but rather normal routine care as this is the control group.

结局指标

主要结局

Live donor kidney transplantation

时间窗: within 1 year of enrollment

Live donor kidney transplantation within one year of enrollment into the study will be the primary outcome and will be collected/identified through electronic medical record system.

次要结局

  • Live Donor Inquiries(within 1 year of enrollment)
  • knowledge of live donation(within 6 months of enrollment)
  • comfort initiating conversations(within 6 months of enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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