Clinical Trials Directory

Trials / Completed

CompletedNCT03916029

Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Menzies School of Health Research · Academic / Other
Sex
All
Age
1 Week – 16 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALfacilitatorTraining and employment of community members to assist the diagnosis and management of otitis media

Timeline

Start date
2019-02-03
Primary completion
2024-06-30
Completion
2024-12-31
First posted
2019-04-16
Last updated
2025-05-21

Locations

20 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT03916029. Inclusion in this directory is not an endorsement.