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NAVKIDS² trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol

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hdl_137186.pdf (827.81 KB)
  (Published version)

Date

2022

Authors

van Zwieten, A.
Ryan, E.G.
Caldwell, P.
Howard, K.
Tong, A.
Craig, J.C.
Alexander, S.I.
Howell, M.
Teixeira-Pinto, A.
Hawley, C.M.

Editors

Advisors

Journal Title

Journal ISSN

Volume Title

Type:

Journal article

Citation

Trials, 2022; 23(1)

Statement of Responsibility

Anita van Zwieten, Elizabeth G. Ryan, Patrina Caldwell, Kirsten Howard, Allison Tong, Jonathan C. Craig, Stephen I. Alexander, Martin Howell, Armando Teixeira, Pinto, Carmel M. Hawley, Shilpanjali Jesudason, Amanda Walker, Fiona Mackie, Sean E. Kennedy, Steven McTaggart, Hugh J. McCarthy, Simon A. Carter, Siah Kim, Reginald Woodleigh, Anna Francis, Alistair R. Mallard, Amélie Bernier, Jean, David W. Johnson, Deirdre Hahn, Donna Reidlinger, Elaine Pascoe, Julie Varghese, Charani Kiriwandeniya, Liza Vergara, Nicholas Larkins, Luke Macauley, Michelle Irving, Rabia Khalid, Chandana Guha, and Germaine Wong

Conference Name

DOI

10.1186/s13063-022-06783-y

Abstract

Background This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS² trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published. Methods/design The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.

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Dissertation Note

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Rights

© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

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Grant ID

http://purl.org/au-research/grants/nhmrc/1170021
 http://purl.org/au-research/grants/nhmrc/1115259
 http://purl.org/au-research/grants/nhmrc/1168994
 http://purl.org/au-research/grants/nhmrc/2014258
 http://purl.org/au-research/grants/nhmrc/1147657
 http://purl.org/au-research/grants/nhmrc/1106716
 http://purl.org/au-research/grants/nhmrc/1092957
 http://purl.org/au-research/grants/nhmrc/1194485

Published Version

https://doi.org/10.1186/s13063-022-06783-y

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Persistent link to this record

https://hdl.handle.net/2440/137186