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

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ClinicalTrials.gov Identifier: NCT03916029
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
The Balnaves Foundation
Northern Territory Government of Australia
The Australian Government Department of Health
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=20) 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 - an Innovative Community-based Service-enhancement Model to Address the Crisis in Ear and Hearing Health of Aboriginal Children in the Northern Territory: a Stepped-wedge Cluster Randomised Trial
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: Facilitator
Certificate II training and employment of local community members as Ear and Hearing Primary Heath Care Facilitators
Behavioral: facilitator
Training and employment of community members to assist the diagnosis and management of otitis media

No Intervention: Control
No Facilitator



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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03916029


Contacts
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Contact: Amy Kimber, BA +61 (08) 8946 amy.kimber@menzies.edu.au
Contact: Jane Nelson, BN +61 (08) 8946 jane.nelson@menzies.edu.au

Locations
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Australia, Northern Territory
Menzies School of Health Research Not yet recruiting
Darwin, Northern Territory, Australia, 0811
Contact: Amanda J Leach, PhD    +61 8 89468560    amanda.leach@menzies.edu.au   
Principal Investigator: Amanda J Leach, PhD         
Sponsors and Collaborators
Menzies School of Health Research
The Balnaves Foundation
Northern Territory Government of Australia
The Australian Government Department of Health
Investigators
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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
ClinicalTrials.gov Identifier: NCT03916029     History of Changes
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: August 16, 2019
Last Verified: August 2019
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
workforce
Aboriginal or Torres Strait Islander
facilitator
education
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms