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Trial registered on ANZCTR


Registration number
ACTRN12618001152213
Ethics application status
Approved
Date submitted
9/07/2018
Date registered
12/07/2018
Date last updated
22/08/2022
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient navigators in children with chronic kidney disease
Scientific title
A multi-centre, waitlist randomised controlled trial of patient navigators to improve the overall self-rated health in children with chronic kidney disease
Secondary ID [1] 295469 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
NAVKIDS2 trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with chronic kidney disease 308730 0
Condition category
Condition code
Renal and Urogenital 307670 307670 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A patient navigator program. The navigator will work with patients, caregivers, health professionals to achieve better care and health through involvement in the social, community and health organisational network. It is a complex intervention and will be individualised, tailored to the needs of the patients and families. The navigator will first identify the needs of the individuals and family, and then design the management plan. The navigator may work with the child and family on a daily basis (either face to face, or via telephone) or less frequently, depending upon the needs of the child and family. The navigator will be available to families during business hours on weekdays. Considering their overall caseload, the time navigators will allocate to each family will be approximately 1 hour per week. The family will have access to the navigator for 24 weeks.
The navigator will follow a four-by-four matrix of tasks and network plan:
1. Identification of task categories for a specific patient and family: navigating tasks may consist of identifying and mitigating barriers with patients and healthcare professionals. They may include telling (explaining where and when a renal biopsy will be done), inquiring (asking about the potential barriers, such as language barriers to attend the next appointment after the biopsy), supporting (listening to the fears about the interventions) and coaching (discussing the potential questions the patients and families may wish to ask in the next appointment).
2. Facilitation for a specific patient and families: the navigator may coordinate communication, seek advice from non-medical and medical staff and help to bring patients in for the appointments.
For example, the patient navigator may help the caregivers to keep track of appointments, particularly when the organisational and executive skills of the child are affected, provide social support, interpret health information provided by the clinicians and facilitate communication within the families when parents are separated. Navigators may help patients to forge a more participatory dialogue with their clinicians, and guiding the patients to ask the right questions, enhancing patient autonomy. Patient navigators can also provide support for caregivers; e.g. managing transport to and from the hospital or coping with the complex organisational network within the hospital, particularly for those of lower literacy, low SES and families from non-English speaking backgrounds.

3. Identification of networks: the navigators will identify all potential network interactions that are relevant to the patients and their families. These may include: the health service providers, the non-clinical staff (administrators and receptionist), and other social support services such as the social workers, community-based services, transportation, and the maintenance of activities and system tasks for patients.
These potential networks will be given to patients and family, ensuring they have full understanding and access to all the services required.
4. Document and review: the navigator will record their own actions (for example: steps taken with or on behalf of the patients and record other activities that are relevant to the navigator role).
Intervention code [1] 301787 0
Other interventions
Comparator / control treatment
The waitlist control is standard care. The control arm (standard care) involved the provision of general care provided by the healthcare professionals in the hospital and outpatient settings without the support of a patient navigator. The waitlist, controlled design has the benefit of allowing all eligible participants to be enrolled and receive the same intervention for the same duration of time, but staggered entry at different time points (different waves) such that participants with delayed entry will serve as controls.
Control group
Active

Outcomes
Primary outcome [1] 306655 0
Self rated health of the children with CKD. The self-rated health is a patient-reported health outcome, is a validated composite measure of the children’s global health status, including both physical and quality of life construct. It is a 5-point Likert scale ranging from (poor health, fair, good, very good and excellent health)
Timepoint [1] 306655 0
The primary study end-point is SRH of the child at the end of 6-month follow-up.
The primary outcome will be collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [1] 349157 0
Utility based quality of life, measured using the Health Utility Index (HUI-3)
Timepoint [1] 349157 0
Collected at baseline, 1, 3, 6, and 12 month follow-ups.
Secondary outcome [2] 349294 0
The number of hospitalisations (measured using a study-specific questionnaire)
Timepoint [2] 349294 0
Collected at 1, 3, 6, 12 month follow-ups.
Secondary outcome [3] 349295 0
Number of missed school days (measured using a study specific questionnaire)
Timepoint [3] 349295 0
Collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [4] 349297 0
All-cause, cardiovascular (CV) and other cause-specific mortality: One-year (short), 5-year (medium) and 10-year (longer) term all-cause, CV and non-CV related mortality will be obtained using data linkage with the National Death Index, housed within the Australia Institute and Health and Welfare (AIHW).
Timepoint [4] 349297 0
1, 5 and 10-year
Secondary outcome [5] 349298 0
Direct health care costs and resource use. Healthcare resource use will be estimated using linked data including hospitalisation records, and Medicare Australia data for outpatient healthcare use (Pharmaceutical Benefit Scheme (PBS) and Medicare Benefits Schedule (MBS). Cost will be estimated by applying DRG or Medicare unit costs and will also include the costs of the patient navigator program.
Timepoint [5] 349298 0
Linkage will occur 12 month after completion of the study.
Secondary outcome [6] 349365 0
Caregiver satisfaction with healthcare including perceived access to care (study specific questionnaire).
Timepoint [6] 349365 0
Collected at baseline, 1, 3, 6, and 12 months.
Secondary outcome [7] 372222 0
Biomarker measured using blood samples - estimated glomerular filtration rate (eGFR*)

*eGFR calculated using a modified Schwartz equation for the estimated glomerular filtration rate.
Timepoint [7] 372222 0
Collected at baseline, 6 and 12 months.
Secondary outcome [8] 372223 0
Biomarker measured from blood sample – urea.
Timepoint [8] 372223 0
Collected at baseline, 6, 12 months.
Secondary outcome [9] 372224 0
Biomarker measured from blood sample - albumin.
Timepoint [9] 372224 0
Collected at baseline, 6, 12 months.
Secondary outcome [10] 372225 0
Biomarker measured from blood sample - bilirubin
Timepoint [10] 372225 0
Collected at baseline, 6, 12 months.
Secondary outcome [11] 372226 0
Biomarker measured from blood sample - alanine transaminase.
Timepoint [11] 372226 0
Collected at baseline, 6, 12 months.
Secondary outcome [12] 372227 0
Biomarker measured from blood sample - alkaline phosphatase.
Timepoint [12] 372227 0
Collected at baseline, 6, 12 months.
Secondary outcome [13] 372228 0
Biomarker measured from blood sample – gamma glutamyl transferase
Timepoint [13] 372228 0
Collected at baseline, 6, 12 months.
Secondary outcome [14] 372229 0
Biomarker measured from blood sample – haemoglobin.
Timepoint [14] 372229 0
Collected at baseline, 6, 12 months.
Secondary outcome [15] 372230 0
Biomarker measured from blood sample – white cell count.
Timepoint [15] 372230 0
Collected at baseline, 6, 12 months.
Secondary outcome [16] 372231 0
Biomarker measured from blood sample – platelets.
Timepoint [16] 372231 0
Collected at baseline, 6, 12 months.
Secondary outcome [17] 413209 0
Biomarkers measured from blood sample – calcium, phosphate, and intact parathyroid hormone.
Timepoint [17] 413209 0
Collected at baseline, 6, 12 months.

Eligibility
Key inclusion criteria
Specifically, to be eligible for the study, participants must satisfy all of the below criteria:
1. Children with CKD (1-5), or CKD-D or CKD-T,
2. Aged 0-16 years, and
3. Low SES background and/or living in "rural/remote areas" . Low SES families are defined as the following: a. Weekly household income (less than the median gross household income, $1250 (AUD) per week), b. Just getting along, poor or very poor self-perceived financial status, c. Single parenting on social benefits, d. Both parents are unemployed, e. Families living in public housing.
Rural/remote areas are classified as having post code in RA2-RA5 area.
4. Caregiver(s) speak English or caregiver(s) speaks a little English but has a family member who can speak English
5. Able to provide consent by the caregiver (and assent- if the child is of 16 years of age)
6. Only one sibling from a family can be included in the study
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Limited life expectancy of less than 12 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence is generated by a computerized random number generator, using a random permuted block design with randomly chosen block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait-list randomized control trial.
(Wait-list group acts as control).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size was calculated for the analysis of the 5-point Likert scale of the SRH (and parent-rated health for younger children) of the child using an ordinal logistic regression. A target of 150-168 patients will be required for the analysis. It is assumed that the dropout rate will be low and so the sample size has not been inflated for dropout.

Data analyses: The main statistical analyses of primary and secondary outcomes comparing the treatment arms will include CKD stage (CKD (1-5), CKD-D, CKD-T) and study centre as fixed effects. Additionally, outcomes with repeated measures will include the time point (modelled as categorical) and the interaction between time point and treatment arm in the model. Additional modelling with ad hoc adjustments may be performed if baseline characteristics are not sufficiently balanced between treatment groups (supporting analyses). The primary outcome analysis is targeted at estimating the difference in SRH of the child between participants randomised to the immediate treatment and waitlisted groups at 6 months post randomisation. All measures of child SRH from baseline to 6 months post-randomisation will be analysed using a cumulative logit mixed effects model, which will include a random intercept for each participant. The primary result will be the treatment effect estimate at 6 months post-randomisation and the 95% CI obtained from the model. SRH of the caregiver will be analysed using similar approaches to SRH of the child. Secondary endpoints that are continuous, repeated measures, such as utility-based quality of life (HUI), will be analysed using linear mixed models. Count data measured at a single time point, such as number of hospitalisations, will be analysed using Poisson regression (or negative binomial or zero-inflated Poisson regression as appropriate) to compare the treatment arms at 6 months post-randomisation. These models will be extended to generalised linear mixed models (GLMMs) for repeatedly measured count outcomes (e.g., number of missed school days). Binary outcomes, such as hospitalisation (none vs at least one) at 6 months post-randomisation, will be analysed using logistic regressions. Descriptive analyses will be performed for the following outcomes: Death (all-cause, CV, non-CV; expected to be low for this patient population); CKD-related outcomes (e.g., graft failure, rejection); Caregiver satisfaction questionnaire items at each time point. A p-value of 0.05 will be used to indicate statistical significance. All analyses after 6 months post randomisation will be considered exploratory analyses.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/06/2020
Actual
17/07/2020
Date of last participant enrolment
Anticipated
30/09/2021
Actual
20/10/2021
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
168
Accrual to date
Final
162
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 11382 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 11384 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [3] 11385 0
Sydney Children's Hospital - Randwick
Recruitment hospital [4] 14668 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [5] 20538 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 23281 0
2145 - Westmead
Recruitment postcode(s) [2] 23282 0
4101 - South Brisbane
Recruitment postcode(s) [3] 23283 0
3052 - Parkville
Recruitment postcode(s) [4] 23284 0
2031 - Randwick
Recruitment postcode(s) [5] 35320 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 300059 0
Government body
Name [1] 300059 0
National Health and Medical Research Council Medical Research Future Fund
Country [1] 300059 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD 4072, Australia
Country
Australia
Secondary sponsor category [1] 299455 0
None
Name [1] 299455 0
Address [1] 299455 0
Country [1] 299455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300906 0
The Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 300906 0
Ethics committee country [1] 300906 0
Australia
Date submitted for ethics approval [1] 300906 0
27/06/2018
Approval date [1] 300906 0
27/11/2018
Ethics approval number [1] 300906 0
HREC/18/SCHN/325

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85230 0
A/Prof Germaine Wong
Address 85230 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85230 0
Australia
Phone 85230 0
+612 8890 6962
Fax 85230 0
+ 612 9633 9351
Email 85230 0
germaine.wong@health.nsw.gov.au
Contact person for public queries
Name 85231 0
Germaine Wong
Address 85231 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85231 0
Australia
Phone 85231 0
+612 8890 6962
Fax 85231 0
+ 612 9633 9351
Email 85231 0
germaine.wong@health.nsw.gov.au
Contact person for scientific queries
Name 85232 0
Germaine Wong
Address 85232 0
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Country 85232 0
Australia
Phone 85232 0
+612 8890 6962
Fax 85232 0
+ 612 9633 9351
Email 85232 0
germaine.wong@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This requirement was not considered/included in the ethics application and approval. However, study level data will be published and publicly available.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNAV-KIDS2 trial: Protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease.2019https://dx.doi.org/10.1186/s12882-019-1325-y
EmbaseNAVKIDS2 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.2022https://dx.doi.org/10.1186/s13063-022-06783-y
EmbaseBaseline characteristics of participants in the NAVKIDS2 trial: a patient navigator program in children with chronic kidney disease.2023https://dx.doi.org/10.1007/s00467-022-05772-2
N.B. These documents automatically identified may not have been verified by the study sponsor.