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临床试验/NCT05154773
NCT05154773已完成不适用

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

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2022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
已完成
入组人数
422
试验地点
2
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 presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.

详细描述

Over a 2.5 year period we will conduct a 2-arm parallel randomized trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of KidneyTIME versus usual care for KTX access over 12 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 potential participants who had been referred to the transplant center for a kidney transplant, are aged 18 years and older, speak English, have internet access, and signed electronic consent as well as provided a text or email address. We will excude patients previously exposed to any component of the intervention.

Each potential participant will be sent an electronic invitation from the principal investigator (a transplant surgeon). This message will briefly described the study and include a personal link to an online consent form describing study procedures and potential risks. A stakeholder Advisory Council, whose members include patients and care partners, will review and provide ongoing feedback on the recruitment and retention plan.

The entire study and the progress tracker will be hosted on Alchemer. Those who sign electronic consent to participate will be automatically guided to a baseline sociodemographic survey (T0). 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 and usual care. Condition assignment of each participant will be concealed from transplant providers, but participants will become aware of their treatment assignment one they access the study educational content.

KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. All components of the intervention were developed through a user-centered design approach by involving kidney failure patients and social network members, to improve usability and increase the likelihood of adoption.

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

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
  • has access to the internet

排除标准

  • Previously exposed to any component of the intervention

研究组 & 干预措施

Usual Care

No Intervention

Routine educational materials from non-study sources through usual Transplant Center protocols including booklets, nurse communications, and the usual care video, a nurse-narrated power-point presentation outlining recipient and donor evaluation, surgery, and recovery processes and outcomes.

KidneyTIME

Experimental

KidneyTIME is a self-directed digital intervention. It contains 25 animated videos, each 1-3 minutes in length, designed to address knowledge gaps and concerns about kidney transplantation and living donation that were identified in literature reviews, formative research, and video development studies as critical for optimal prospective kidney recipient and donor participation in LDKT. We chose 6 videos from the entire series to be delivered sequentially for a total duration of 13 minutes. After completing the proscribed videos and an immediate-post exposure survey, everyone then received a link to access all 25 videos centralized on a website where the videos were activated for sharing through various modalities, including text, email, Facebook, and Twitter. The website could be accessed using this link from any electronic device throughout the study. Prompts to use the intervention were sent once a week for 3 weeks and then monthly for 12 months.

干预措施: Kidney donation and transplant information made easy (Behavioral)

结局指标

主要结局

Living Donor Inquiry

时间窗: 12 months

Living donor inquiry to the transplant center on behalf of the participant by telephone, email, or mail within 12 months from enrollment. Each inquiry is captured for all patients as a discrete field in the electronic medical record within 12 months from enrollment. An inquiry includes any request for information or evaluation to be a living kidney donor in which the recipients' name is specified.

次要结局

  • Living Donor Kidney Transplant Knowledge(Immediately post baseline, 1 month, 6 month, and 12 months)
  • Living Donor Kidney Transplant Concerns(Immediately post baseline, 1 month, 6 month, and 12 months)
  • Living Donor Kidney Transplant Readiness(Immediately post baseline, 1 month, 6 month, and 12 months)
  • Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior(Immediately post baseline, 1 month, 6 month, and 12 months)
  • LDKT Concerns Scale(immediately post baseline, 1 month, 6 month, and 12 months)
  • LDKT action behaviors(immediately post baseline, 1 month, 6 month, and 12 months)
  • LDKT Knowledge scale(immediately post baseline, 1 month, 6 month, and 12 months)
  • LDKT Readiness(immediately post baseline, 1 month, 6 month, and 12 months)

研究者

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

Liise Kayler

Primary Investigator

State University of New York at Buffalo

研究点 (2)

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