NCT03916029

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5.4 years

First QC Date

April 12, 2019

Last Update Submit

May 18, 2025

Conditions

Keywords

primary health careworkforceAboriginal or Torres Strait Islanderfacilitatoreducation

Outcome Measures

Primary Outcomes (1)

  • Ear assessment

    Proportion of children who have had a documented ear assessment

    6-monthly

Secondary Outcomes (4)

  • Prevalence of otitis media

    6-monthly

  • Management plan

    6-monthly

  • Appropriate management plan

    6-monthly

  • Follow-up

    6-monthly

Other Outcomes (1)

  • Prevalence of hearing loss among school age children

    6-monthly

Study Arms (2)

Facilitator

ACTIVE COMPARATOR

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.

Behavioral: facilitator

Control

NO INTERVENTION

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

Interventions

facilitatorBEHAVIORAL

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

Facilitator

Eligibility Criteria

Age1 Week - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Ali Curung

Ali Curung, Northern Territory, Australia

Location

Ampilatwatja

Ampilatwatja, Northern Territory, Australia

Location

Darwin

Darwin, Northern Territory, 0800, Australia

Location

Galiwin'ku

Galiwin'ku, Northern Territory, Australia

Location

Gunbalanya

Gunbalanya, Northern Territory, Australia

Location

Kalkarindji Primary Health Centre

Kalkarindji, Northern Territory, 0852, Australia

Location

Wurli Wurlinjang Health Service

Katherine, Northern Territory, 0850, Australia

Location

Lajamanu Primary Health Centre

Lajamanu, Northern Territory, Australia

Location

Mala'la Health Service

Maningrida, Northern Territory, 0820, Australia

Location

Milikapiti Community Health Centre

Milikapiti, Northern Territory, Australia

Location

Milingimbi Health Clinic

Milingimbi, Northern Territory, 0822, Australia

Location

Minjilang Community Health Centre

Minjilang, Northern Territory, Australia

Location

Nauiyu

Nauiyu, Northern Territory, Australia

Location

Palumpa Community Health Centre

Palumpa, Northern Territory, 0822, Australia

Location

Pirlangimpi Health Clinic

Pirlangimpi, Northern Territory, 0822, Australia

Location

Ti Tree Community Health Centre

Ti Tree, Northern Territory, 0872, Australia

Location

Wadeye Community Health Centre

Wadeye, Northern Territory, 0822, Australia

Location

Warruwi Community Health Centre

Warruwi, Northern Territory, 0822, Australia

Location

Julanimawu (Nguiu) Community Health centre

Wurrumiyanga, Northern Territory, 0822, Australia

Location

Yirrkala Clinic

Yirrkala, Northern Territory, 0880, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Otitis MediaHearing Loss, Conductive

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic DiseasesHearing LossHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amanda Leach, PhD

    Menzies School of Health Research

    PRINCIPAL INVESTIGATOR
  • Kelvin Kong, MBBS

    Newcastle University

    STUDY DIRECTOR
  • Peter S Morris, MBBS, PhD

    Menzies School of Health Research

    STUDY DIRECTOR
  • Alan Cass, MBBS, PhD

    Menzies School of Health Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data analyst will be blinded to the cluster allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

February 3, 2019

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations