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.|
|ClinicalTrials.gov Identifier: NCT03916029|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : August 16, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
Active Comparator: Facilitator
Certificate II training and employment of local community members as Ear and Hearing Primary Heath Care Facilitators
Training and employment of community members to assist the diagnosis and management of otitis media
No Intervention: Control
- Ear assessment [ Time Frame: 6-monthly ]Proportion of children who have had a documented ear assessment
- Prevalence of otitis media [ Time Frame: 6-monthly ]Proportion of children with any otitis media
- Management plan [ Time Frame: 6-monthly ]Proportion of otitis media cases with a management plan
- Appropriate management plan [ Time Frame: 6-monthly ]Proportion of management plans that are appropriate
- Follow-up [ Time Frame: 6-monthly ]Proportion of cases with follow-up within 10 days
- Prevalence of hearing loss among school age children [ Time Frame: 6-monthly ]Proportion of school age children with conductive hearing loss
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
|Contact: Amy Kimber, BA||+61 (08) firstname.lastname@example.org|
|Contact: Jane Nelson, BN||+61 (08) email@example.com|
|Australia, Northern Territory|
|Menzies School of Health Research||Not yet recruiting|
|Darwin, Northern Territory, Australia, 0811|
|Contact: Amanda J Leach, PhD +61 8 89468560 firstname.lastname@example.org|
|Principal Investigator: Amanda J Leach, PhD|
|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|