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Updated: Aug 27, 2025
Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in
Anita van Zwieten1,2, Elizabeth G Ryan3,4, Patrina Caldwell5,6
1Centre for Kidney Research at The Children's Hospital at Westmead, Westmead, New South Wales, Australia. anita.vanzwieten@sydney.edu.au.
Insights
This study updates the NAVKIDS2 trial protocol for patient navigators assisting children with chronic kidney disease (CKD) facing social disadvantage. It details protocol amendments and the statistical analysis plan for this important pediatric CKD research.
Area of Science:
- Pediatric Nephrology
- Clinical Trial Methodology
- Health Services Research
Background:
- The NAVKIDS2 trial investigates patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage.
- This update addresses protocol modifications implemented during the trial and presents the statistical analysis plan (SAP).
Purpose of the Study:
- To summarize key protocol changes made to the NAVKIDS2 trial since its initial publication.
- To provide the detailed statistical analysis plan (SAP) for the NAVKIDS2 trial.
Main Methods:
- The study details methodological amendments including eligibility criteria adjustments, site changes, sample size reduction, and adaptation to virtual procedures due to COVID-19.
- Key changes encompass broadening patient inclusion, modifying age ranges, and incorporating new outcome measures and assessment schedules.
Main Results:
- Protocol amendments were finalized before study completion and data analysis.
- The statistical analysis plan is now published, ensuring transparency in data interpretation.
Conclusions:
- These protocol updates and the SAP ensure the robust and transparent analysis of the NAVKIDS2 trial data.
- The modifications reflect adaptive trial management in response to evolving circumstances and research needs.
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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