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

Otitis Media Clinical Trial

— HfLI  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Hearing Loss
• Hearing Loss, Conductive
• Otitis
• Otitis Media

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