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Clinical Trials/NCT03916029
NCT03916029
Completed
Not Applicable

The Hearing for Learning Initiative - a Service-enhancement Model of Ear Health Facilitators to Address the Crisis in Ear and Hearing Health of Aboriginal Children in the Northern Territory: a Stepped-wedge Cluster Randomised Trial

Menzies School of Health Research20 sites in 1 country18 target enrollmentFebruary 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otitis Media
Sponsor
Menzies School of Health Research
Enrollment
18
Locations
20
Primary Endpoint
Ear assessment
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services.

This initiative will address the following research question: In urban, rural and remote Aboriginal communities in the Northern Territory, does employment, training and integration of local Ear and Hearing Clinical and Education Support Officers into health and education services (the Hearing for Learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of Aboriginal and Torres Strait Islander children, during a four year trial period?

Detailed Description

Background: Australian Indigenous children achieve lower scores in school readiness and education outcomes than their non-Indigenous peers. Chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. Local problem: Failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children. This Hearing for Learning Initiative aims to improve health care and education services. Interventions: The intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention). Trial design: A stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the HfLI (intervention) periods with no HfLI (control) periods. Participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates. Outcomes: the primary outcome is the change in the proportion of Aboriginal and Torres Strait Islander children who receive an ear assessment, between intervention and control periods.

Registry
clinicaltrials.gov
Start Date
February 3, 2019
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aboriginal or Torres Strait Islander, resident in participating community (cluster)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Ear assessment

Time Frame: 6-monthly

Proportion of children who have had a documented ear assessment

Secondary Outcomes

  • Prevalence of otitis media(6-monthly)
  • Appropriate management plan(6-monthly)
  • Management plan(6-monthly)
  • Follow-up(6-monthly)

Study Sites (20)

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