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临床试验/NCT07072767
NCT07072767尚未招募不适用

Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2027年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
430
试验地点
1
主要终点
Living donor inquiry

研究概览

简要总结

The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KidneyTIME+) with or without human guide . Following consent and baseline assessment, participants are randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide.

详细描述

Over a 3-year period the investigators will conduct a pilot 2-arm parallel randomized trial among patients referred for kidney transplantation at a single transplant center to compare the effects of KidneyTIME+ with or without ongoing human support for KTX access over 6 months of intervention use and follow-up.

Participants will be recruited from the Transplant program at Erie County Medical Center, a safety-net hospital in Buffalo, New York. Each week, electronic records will be accessed to identify patients and their carers who present for transplant evaluation at the transplant center for a kidney transplant, are aged 18 years and older, speak English, and are competent to provide informed consent . The investigators will exclude patients previously exposed to any component of the intervention, listed for transplantation at another center, and seeking multiorgan transplantation.

A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan. They will also provide input on assistive dissemination tools for organizations to engage individuals to use the resource.

Each potential participant will be invited to the study by a researcher who will describe the study and answer and questions, and provide a copy of the consent form describing study procedures and potential risks.

Those who sign electronic consent to participate will be asked to complete a baseline sociodemographic and pre-test survey. Upon completion, computer-generated randomization will stratify participants by self-reported race (Black versus Other), with equal allocation to 2 treatment arms: the KidneyTIME+ intervention with or without human guide. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment once they access the human guide.

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 (Care Provider, Outcomes Assessor)

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

  • referred to the transplant center for a kidney transplant
  • aged 18 years and older
  • speaks English

排除标准

  • Previously exposed to any component of the intervention
  • Listed for a kidney transplant at another center (multilisted)
  • Seeking multiorgan transplantation

研究组 & 干预措施

KidneyTime-2 with human support

Experimental

KidneyTIME-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Human guide support offered over a 6 month period to encourage use of the intervention and donor outreach.

干预措施: Digital education outreach intervention for kidney transplant access and human guide (Behavioral)

KidneyTime-2 without human support

Active Comparator

KidneyTime-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Routine clinical support from non-study sources through usual Transplant Center protocols including clinic provider communications.

干预措施: Digital education outreach intervention for kidney transplant access only (unguided) (Behavioral)

结局指标

主要结局

Living donor inquiry

时间窗: Baseline, post baseline 6 months

Count of living donor inquires to the transplant center on behalf of the study participants within 6 months from enrollment. Each inquiry (telephone call, email, letter) is counted and added to a discrete field for all patients in the electronic medical record.

次要结局

  • LDKT Perceived understanding(Baseline, post baseline 6 months)
  • LDKT Conversational self-efficacy(Baseline, post baseline 6 months)
  • LDKT Beliefs scale(Baseline, post baseline 6 months)
  • Donor outreach behaviors(Baseline, post baseline 6 months)

研究者

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

Liise Kayler

Principal Investigator

State University of New York at Buffalo

研究点 (1)

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