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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03916029


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT03916029
Ethics application status
Date submitted
12/04/2019
Date registered
16/04/2019
Date last updated
16/08/2019

Titles & IDs
Public title
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
Scientific 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
Secondary ID [1] 0 0
TEHREC -18-3264
Secondary ID [2] 0 0
R813
Universal Trial Number (UTN)
Trial acronym
HfLI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 0 0
Conductive Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Ear 0 0 0 0
Other ear disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - facilitator

Active Comparator: Facilitator - Certificate II training and employment of local community members as Ear and Hearing Primary Heath Care Facilitators

No Intervention: Control - No Facilitator


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

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ear assessment - Proportion of children who have had a documented ear assessment
Timepoint [1] 0 0
6-monthly
Secondary outcome [1] 0 0
Prevalence of otitis media - Proportion of children with any otitis media
Timepoint [1] 0 0
6-monthly
Secondary outcome [2] 0 0
Management plan - Proportion of otitis media cases with a management plan
Timepoint [2] 0 0
6-monthly
Secondary outcome [3] 0 0
Appropriate management plan - Proportion of management plans that are appropriate
Timepoint [3] 0 0
6-monthly
Secondary outcome [4] 0 0
Follow-up - Proportion of cases with follow-up within 10 days
Timepoint [4] 0 0
6-monthly

Eligibility
Key inclusion criteria
Aboriginal or Torres Strait Islander, resident in participating
community (cluster)
Minimum age
No limit
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0811 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Balnaves Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Territory Government of Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Australian Government Department of Health
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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?
Trial website
https://clinicaltrials.gov/show/NCT03916029
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Leach, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Kimber, BA
Address 0 0
Country 0 0
Phone 0 0
+61 (08) 8946
Fax 0 0
Email 0 0
amy.kimber@menzies.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03916029

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NT
Funding & Sponsors
Funding source category [1] 4
Charities/Societies/Foundations
Name [1] 4
The Balnaves Foundation
Address [1] 4
Macquarie Street, Sydney
Country [1] 4
Australia
Funding source category [2] 5
Government body
Name [2] 5
Northern Territory Government
Address [2] 5
Mitchell Street, Darwin
Country [2] 5
Australia
Funding source category [3] 6
Government body
Name [3] 6
Australian Federal Government
Address [3] 6
Country [3] 6
Australia
Primary sponsor
Other
Primary sponsor name
Menzies School of Health Research
Primary sponsor address
PO Box 41096
Casuarina, 0811
Northern Territory
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7
Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research (EC 00153)
Address [1] 7
Ethics Administrator Officer, Human Research Ethics Committee (HREC) of the Northern Territory Department of Health and Menzies School of Health Research, PO Box 41096, Casuarina NT 0811.
Country [1] 7
Australia
Date submitted for ethics approval [1] 7
07/11/2018
Approval date [1] 7
05/04/2019
Ethics approval number [1] 7
HREC 2018-3264 20190405
Ethics committee name [2] 8
Central Australian Human Research Ethics Committee
Address [2] 8
PO Box 4066 Alice Springs NT Australia 0871
Country [2] 8
Australia
Date submitted for ethics approval [2] 8
16/01/2019
Approval date [2] 8
18/04/2019
Ethics approval number [2] 8
CA-19-3308
 
Public notes

Contacts
Principal investigator
Title 81 0
Prof
Name 81 0
Amanda Leach
Address 81 0
POBox 41096
Country 81 0
Australia
Phone 81 0
+61889468560
Fax 81 0
Email 81 0
amanda.leach@menzies.edu.au
Contact person for public queries
Title 82 0
Prof
Name 82 0
Amanda Leach
Address 82 0
POBox 41096
Country 82 0
Australia
Phone 82 0
+61889468560
Fax 82 0
Email 82 0
amanda.leach@menzies.edu.au
Contact person for scientific queries
Title 83 0
Prof
Name 83 0
Amanda Leach
Address 83 0
POBox 41096
Country 83 0
Australia
Phone 83 0
+61889468560
Fax 83 0
Email 83 0
amanda.leach@menzies.edu.au