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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03916029
Other study ID # R813
Secondary ID TEHREC -18-3264C
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 3, 2019
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Menzies School of Health Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Week to 16 Years
Eligibility Inclusion Criteria: Aboriginal or Torres Strait Islander, resident in participating community (cluster) Exclusion Criteria: none

Study Design


Intervention

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

Locations

Country Name City State
Australia Ali Curung Ali Curung Northern Territory
Australia Ampilatwatja Ampilatwatja Northern Territory
Australia Darwin Darwin Northern Territory
Australia Galiwin'ku Galiwin'ku Northern Territory
Australia Gunbalanya Gunbalanya Northern Territory
Australia Kalkarindji Primary Health Centre Kalkarindji Northern Territory
Australia Wurli Wurlinjang Health Service Katherine Northern Territory
Australia Lajamanu Primary Health Centre Lajamanu Northern Territory
Australia Mala'la Health Service Maningrida Northern Territory
Australia Milikapiti Community Health Centre Milikapiti Northern Territory
Australia Milingimbi Health Clinic Milingimbi Northern Territory
Australia Minjilang Community Health Centre Minjilang Northern Territory
Australia Nauiyu Nauiyu Northern Territory
Australia Palumpa Community Health Centre Palumpa Northern Territory
Australia Pirlangimpi Health Clinic Pirlangimpi Northern Territory
Australia Ti Tree Community Health Centre Ti Tree Northern Territory
Australia Wadeye Community Health Centre Wadeye Northern Territory
Australia Warruwi Community Health Centre Warruwi Northern Territory
Australia Julanimawu (Nguiu) Community Health centre Wurrumiyanga Northern Territory
Australia Yirrkala Clinic Yirrkala Northern Territory

Sponsors (3)

Lead Sponsor Collaborator
Menzies School of Health Research Australian Government Department of Health and Ageing, Northern Territory Government of Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Prevalence of hearing loss among school age children Proportion of school age children with conductive hearing loss 6-monthly
Primary Ear assessment Proportion of children who have had a documented ear assessment 6-monthly
Secondary Prevalence of otitis media Proportion of children with any otitis media 6-monthly
Secondary Management plan Proportion of otitis media cases with a management plan 6-monthly
Secondary Appropriate management plan Proportion of management plans that are appropriate 6-monthly
Secondary Follow-up Proportion of cases with follow-up within 10 days 6-monthly
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