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Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media (HfLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03916029
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : October 8, 2020
Australian Government Department of Health and Ageing
Northern Territory Government of Australia
Information provided by (Responsible Party):
Menzies School of Health Research

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?

Condition or disease Intervention/treatment Phase
Otitis Media Conductive Hearing Loss Behavioral: facilitator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Stepped-wedge cluster randomised controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Data analyst will be blinded to the cluster allocation.
Primary Purpose: Health Services Research
Official 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
Actual Study Start Date : February 3, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: facilitator
Training and employment of community members to assist the diagnosis and management of otitis media

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

Primary Outcome Measures :
  1. Ear assessment [ Time Frame: 6-monthly ]
    Proportion of children who have had a documented ear assessment

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Prevalence of hearing loss among school age children [ Time Frame: 6-monthly ]
    Proportion of school age children with conductive hearing loss

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Exclusion Criteria: none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03916029

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Contact: Amy Kimber, BA +61 (08) 8946
Contact: Jane Nelson, BN +61 (08) 8946

Show Show 21 study locations
Sponsors and Collaborators
Menzies School of Health Research
Australian Government Department of Health and Ageing
Northern Territory Government of Australia
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Principal Investigator: Amanda Leach, PhD Menzies School of Health Research
Study Director: 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
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Responsible Party: Menzies School of Health Research Identifier: NCT03916029    
Other Study ID Numbers: R813
TEHREC -18-3264 ( Other Identifier: Ethics Committee )
CAHREC - 19-330 ( Other Identifier: Ethics Committee )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Menzies School of Health Research:
primary health care
Aboriginal or Torres Strait Islander
Additional relevant MeSH terms:
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Hearing Loss
Otitis Media
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases