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Completed

NCT Number: NCT03916029

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

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?

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Key information

Age range

1 week–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ali Curung, Northern Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Facilitator

Behavioral

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

Primary outcomes

  1. Ear assessment

    Time frame: 6-monthly

    Proportion of children who have had a documented ear assessment

Secondary outcomes

  1. Prevalence of otitis media

    Time frame: 6-monthly

    Proportion of children with any otitis media

  2. Management plan

    Time frame: 6-monthly

    Proportion of otitis media cases with a management plan

  3. Appropriate management plan

    Time frame: 6-monthly

    Proportion of management plans that are appropriate

  4. Follow-up

    Time frame: 6-monthly

    Proportion of cases with follow-up within 10 days

Other outcomes

  1. Prevalence of hearing loss among school age children

    Time frame: 6-monthly

    Proportion of school age children with conductive hearing loss

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • Australian Government Department of Health and Ageing
  • Northern Territory Government of Australia

Registry information

Official study title

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

Acronym: HfLI

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 16, 2019
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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