Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT): A Clinical Research Protocol for a Pilot Randomized Controlled Trial to Increase Living Kidney Donation.

IF 1.6 Q3 UROLOGY & NEPHROLOGY
Canadian Journal of Kidney Health and Disease Pub Date : 2023-10-30 eCollection Date: 2023-01-01 DOI:10.1177/20543581231205340
Anne-Marie Selzler, Parastoo Molla Davoodi, Scott Klarenbach, Ngan N Lam, Terry Smith, Abigail Ackroyd, Natasha Wiebe, Bonnie Corradetti, Sharron Ferdinand, Dorothy Iyekekpolor, Gordon Smith, Nancy Verdin, Aminu K Bello, Kevin Wen, Soroush Shojai
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引用次数: 0

Abstract

Background: Living donor kidney transplantation (LDKT) is the optimal treatment for eligible patients with kidney failure, although it is underutilized. Contextually tailored patient- and family-centered interventions may be effective to increase LDKT.

Objective: We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT.

Design: Non-blinded single-center pilot randomized controlled trial with a qualitative interview component.

Setting: Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area.

Patients: English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate.

Measurements: Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability.

Methods: Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually.

Limitations: Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded.

Conclusions: This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial.

Trial registration number: NCT04666545.

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多学科支持获得活体肾脏移植(MuST AKT):增加活体肾脏捐赠的随机对照试验的临床研究方案。
背景:活体肾移植(LDKT)是符合条件的肾衰竭患者的最佳治疗方法,尽管它没有得到充分利用。以患者和家庭为中心的情境定制干预措施可能会有效增加LDKT。目的:我们概述了一项方案,以测试旨在增加LDKT的多学科支持获得活体供体肾移植(MuST-AKT)干预的可行性。设计:采用定性访谈成分的非盲单中心随机对照试验。背景:阿尔伯塔省北部地区的学术移植转诊中心,其集水区人口超过200万。患者:年龄在18至75岁之间的讲英语的肾移植患者有资格参加。测量:可行性将通过招募、保留和完成率、治疗忠诚度、干预依从性、参与干预和可接受性等指标进行评估。方法:参与者将以1:1的比例随机分配到标准护理(对照组)或接受标准护理加MuST AKT干预的实验组,这是一项以人为中心的计划,旨在帮助并使肾移植候选人达到接受LDKT所需的效果。干预包括一次介绍性会议和4次亲自或虚拟授课的干预会议。局限性:无法推断MuST AKT干预的疗效/有效性。本研究为非盲法研究。结论:这项试点研究是我们在医疗保健管辖范围内增加LDKT的更广泛举措的第一步。这项研究的结果将用于为未来确定的随机对照试验的发展提供信息。试验注册号:NCT04666545。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.00
自引率
5.90%
发文量
84
审稿时长
12 weeks
期刊介绍: Canadian Journal of Kidney Health and Disease, the official journal of the Canadian Society of Nephrology, is an open access, peer-reviewed online journal that encourages high quality submissions focused on clinical, translational and health services delivery research in the field of chronic kidney disease, dialysis, kidney transplantation and organ donation. Our mandate is to promote and advocate for kidney health as it impacts national and international communities. Basic science, translational studies and clinical studies will be peer reviewed and processed by an Editorial Board comprised of geographically diverse Canadian and international nephrologists, internists and allied health professionals; this Editorial Board is mandated to ensure highest quality publications.
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