A multicenter, waitlisted, staggered entry randomised controlled trial of patient navigators in children with chronic kidney disease
Principal Investigators: Professor Germaine Wong
Clinical Project Manager: Julie Varghese (AKTN)
Trial Number: 18.01
Population: Children aged 0 to 16 years with CKD (Stages 1-5), CKD-Dialysis and CKD-Transplant and of low socioeconomic status backgrounds and/or remote geographical locations
Intervention: Patient navigator vs no patient navigator (immediate patient navigator vs delayed patient navigator)
Follow-up: 12 months
Primary outcome: To assess if a patient navigator program improves the overall health and well-being of the child compared to standard care
Status: Recruitment complete
Recruitment: 162 participants recruited across Australia
NAVKIDS² Study Website: Visit the dedicated study website here
Publication (1): Study protocol paper. Read the full article visa the links below:
Full text version at BMC Nephrology website (open access) or in PDF Copy.
Publication (2): Statistical Analysis Plan (SAP) and update to protocol paper. Read the full article visa the links below:
Full text version at BMC Nephrology website (open access) or in PDF Copy.
Protocol: Full study protocol. View the PDF Copy.
Publication (3): Baseline characteristic paper. View the PDF Copy.
Trial Summary
CKD is a devastating illness associated with increased mortality, reduced quality of life, impaired growth, neurocognitive impairment and psychosocial maladjustment in children. The overall annual mortality rate for children on dialysis is 35 per 1000 population and is thirty-fold higher than children without CKD. Our prior observational data have indicated that social disadvantage is a key factor that affects health in children with CKD.
Patient navigators are trained non-medical personnel who assist patients with complex and/or chronic conditions journey through the continuum of care and transit across different care settings. They help vulnerable and underserved populations with chronic illness to better understand their diagnoses, treatment options, and available resources, to guide them through the complex medical system and to overcome barriers to health care access and bridge gaps in transitions of care.
The study aims to see if a patient navigation program will lead to improvement in the provision of care and overall health of children with CKD and if it is cost-effective.
The study has already received funding from the National Health and Medical Council Medical Research Future Fund Rare Cancers, Rare Diseases and Unmet Need Initiative.