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Trial from ANZCTR

A multi-centre, staggered entry, waitlist randomised controlled trial of patient navigators to improve the overall self-rated health in children with chronic kidney disease

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 9/1/2019)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618001152213

Date registered

12 July 2018

Health condition

Children with chronic kidney disease

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland, Victoria

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

04 March 2019

Ethics application status

Approved

Brief summary

The NAVKID2 trial is a multi-centre, staggered entry, waitlisted randomised controlled trial that assesses the health benefits and costs of a patient navigator program in children with chronic kidney disease (CKD) stages 3-5, on dialysis (CKD-D) and with kidney transplants (CKD-T) and of low socioeconomic backgrounds. 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. Such large discrepancies in mortality rates remain unchanged despite medical advances over the past two decades. The key findings of our observational KCAD study indicated that poor health in children with CKD is not only attributed to the direct influence of the chronic illness but also reflects outcomes of the complex pathway that defines equitable access to healthcare. We found that children with CKD of the lowest and second lowest socioeconomic status (SES) quartiles were at least 3 and 2 times more likely to experience poorer overall health compared to the highest SES quartile.
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 the vulnerable and underserved populations with chronic illness to better understand their diagnoses, treatment options, and available resources, to guide them through the very complex medical system and to overcome barriers to health care access and bridge gaps in transitions of care. Using a staggered entry, waitlist randomised control design, this study will aim to: 1. Assesses the impact of a patient navigator program on the overall health and well-being of children with CKD in a multi-centre, staggered-entry, waitlisted randomised controlled trial.
2. Determine the cost-effectiveness of a patient-navigator program compare with standard care.
3. Identify the barriers and facilitators of developing and implementing a patient navigator program in clinical practice.

Eligibility

Key inclusion criteria

Specifically, to be eligible for the study, participants must satisfy all of the below criteria:1. Children with CKD (3-5), or CKD-D or CKD-T, 2. Aged 3-18 years, and
3. Low SES background. Low SES families are defined as the following: a. Weekly household income (less than the median gross household income, $1250 (AUD) per week), b. 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.

Minimum age

3 Years

Maximum age

18 Years

Gender

Both males and females

Key exclusion criteria

1. Limited life expectancy of less than 12 months and 2. Unable to provide consent by the caregiver (and assent– if the child is 16 years or over).

Contact details and further information

Primary Sponsor

Type: University
Name: University of Sydney
Address: Sydney School of Public Health, Edward Ford Building (A27), Fisher Road, University of Sydney NSW 2006
Country: Australia

Contact person for information and recruitment

A/Prof Germaine Wong
Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, Corner of Hawkesbury Road and Hainsworth Street, Westmead 2145, NSW
Australia
+612 8890 6962
germaine.wong@health.nsw.gov.au