TY - JOUR
T1 - NAVKIDS2 trial
T2 - 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
AU - van Zwieten, Anita
AU - Ryan, Elizabeth G.
AU - Caldwell, Patrina
AU - Howard, Kirsten
AU - Tong, Allison
AU - Craig, Jonathan C.
AU - Alexander, Stephen I.
AU - Howell, Martin
AU - Teixeira-Pinto, Armando
AU - Hawley, Carmel M.
AU - Jesudason, Shilpanjali
AU - Walker, Amanda
AU - Mackie, Fiona
AU - Kennedy, Sean E.
AU - McTaggart, Steven
AU - McCarthy, Hugh J.
AU - Carter, Simon A.
AU - Kim, Siah
AU - Woodleigh, Reginald
AU - Francis, Anna
AU - Mallard, Alistair R.
AU - Bernier-Jean, Amélie
AU - Johnson, David W.
AU - Hahn, Deirdre
AU - Reidlinger, Donna
AU - Pascoe, Elaine
AU - Varghese, Julie
AU - Kiriwandeniya, Charani
AU - Vergara, Liza
AU - Larkins, Nicholas
AU - Macauley, Luke
AU - Irving, Michelle
AU - Khalid, Rabia
AU - Guha, Chandana
AU - Wong, Germaine
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Adolescents
KW - Children
KW - Chronic kidney disease
KW - Dialysis
KW - Health disparities
KW - Kidney transplantation
KW - Patient navigator
KW - Randomised controlled trial
KW - Socioeconomic disadvantage
UR - http://www.scopus.com/inward/record.url?scp=85138850685&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1170021
U2 - 10.1186/s13063-022-06783-y
DO - 10.1186/s13063-022-06783-y
M3 - Article
C2 - 36175942
AN - SCOPUS:85138850685
VL - 23
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 824
ER -