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

NCT ID: NCT03916029

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-03

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Otitis Media Conductive Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stepped-wedge cluster randomised controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
Data analyst will be blinded to the cluster allocation.

Study Groups

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Facilitator

120 hours training for local community members delivered on-country face-to-face during 6 4-day weeks and over a 3-6 month period. Certificate II modules in Aboriginal Primary Health Care, ear and hearing health skills development (otoscopy, tympanometry, and hearScreen) and employment as Ear Health Facilitators to the end of the trial.

Group Type ACTIVE_COMPARATOR

facilitator

Intervention Type BEHAVIORAL

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

Control

No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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facilitator

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria: none
Minimum Eligible Age

1 Week

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Australian Government Department of Health and Ageing

OTHER_GOV

Sponsor Role collaborator

Northern Territory Government of Australia

OTHER_GOV

Sponsor Role collaborator

Menzies School of Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Leach, PhD

Role: PRINCIPAL_INVESTIGATOR

Menzies School of Health Research

Kelvin Kong, MBBS

Role: STUDY_DIRECTOR

Newcastle University

Peter S Morris, MBBS, PhD

Role: STUDY_DIRECTOR

Menzies School of Health Research

Alan Cass, MBBS, PhD

Role: STUDY_DIRECTOR

Menzies School of Health Research

Locations

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Ali Curung

Ali Curung, Northern Territory, Australia

Site Status

Ampilatwatja

Ampilatwatja, Northern Territory, Australia

Site Status

Darwin

Darwin, Northern Territory, Australia

Site Status

Galiwin'ku

Galiwin'ku, Northern Territory, Australia

Site Status

Gunbalanya

Gunbalanya, Northern Territory, Australia

Site Status

Kalkarindji Primary Health Centre

Kalkarindji, Northern Territory, Australia

Site Status

Wurli Wurlinjang Health Service

Katherine, Northern Territory, Australia

Site Status

Lajamanu Primary Health Centre

Lajamanu, Northern Territory, Australia

Site Status

Mala'la Health Service

Maningrida, Northern Territory, Australia

Site Status

Milikapiti Community Health Centre

Milikapiti, Northern Territory, Australia

Site Status

Milingimbi Health Clinic

Milingimbi, Northern Territory, Australia

Site Status

Minjilang Community Health Centre

Minjilang, Northern Territory, Australia

Site Status

Nauiyu

Nauiyu, Northern Territory, Australia

Site Status

Palumpa Community Health Centre

Palumpa, Northern Territory, Australia

Site Status

Pirlangimpi Health Clinic

Pirlangimpi, Northern Territory, Australia

Site Status

Ti Tree Community Health Centre

Ti Tree, Northern Territory, Australia

Site Status

Wadeye Community Health Centre

Wadeye, Northern Territory, Australia

Site Status

Warruwi Community Health Centre

Warruwi, Northern Territory, Australia

Site Status

Julanimawu (Nguiu) Community Health centre

Wurrumiyanga, Northern Territory, Australia

Site Status

Yirrkala Clinic

Yirrkala, Northern Territory, Australia

Site Status

Countries

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Australia

References

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Kong K, Cass A, Leach AJ, Morris PS, Kimber A, Su JY, Oguoma VM. A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial. Trials. 2021 Jun 16;22(1):403. doi: 10.1186/s13063-021-05215-7.

Reference Type DERIVED
PMID: 34134736 (View on PubMed)

Other Identifiers

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TEHREC -18-3264

Identifier Type: OTHER

Identifier Source: secondary_id

CAHREC - 19-330

Identifier Type: OTHER

Identifier Source: secondary_id

R813

Identifier Type: -

Identifier Source: org_study_id

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