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Trial details imported from ClinicalTrials.gov

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

Titles & IDs
Public title
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
Scientific 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
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
BEHAVIORAL - facilitator

Active comparator: Facilitator - 120 hours training for local community members delivered on-country face-to-face during 6 4-day weeks and over a 3-6 month period. Certificate II modules in Aboriginal Primary Health Care, ear and hearing health skills development (otoscopy, tympanometry, and hearScreen) and employment as Ear Health Facilitators to the end of the trial.

No intervention: Control - No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.


BEHAVIORAL: facilitator
Training and employment of community members to assist the diagnosis and management of otitis media
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ear assessment
Timepoint [1] 0 0
6-monthly
Secondary outcome [1] 0 0
Prevalence of otitis media
Timepoint [1] 0 0
6-monthly
Secondary outcome [2] 0 0
Management plan
Timepoint [2] 0 0
6-monthly
Secondary outcome [3] 0 0
Appropriate management plan
Timepoint [3] 0 0
6-monthly
Secondary outcome [4] 0 0
Follow-up
Timepoint [4] 0 0
6-monthly

Eligibility
Key inclusion criteria
Aboriginal or Torres Strait Islander, resident in participating community (cluster)
Minimum age
1 Week
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose of the study
Other
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Ali Curung - Ali Curung
Recruitment hospital [2] 0 0
Ampilatwatja - Ampilatwatja
Recruitment hospital [3] 0 0
Darwin - Darwin
Recruitment hospital [4] 0 0
Galiwin'ku - Galiwin'ku
Recruitment hospital [5] 0 0
Gunbalanya - Gunbalanya
Recruitment hospital [6] 0 0
Kalkarindji Primary Health Centre - Kalkarindji
Recruitment hospital [7] 0 0
Wurli Wurlinjang Health Service - Katherine
Recruitment hospital [8] 0 0
Lajamanu Primary Health Centre - Lajamanu
Recruitment hospital [9] 0 0
Mala'la Health Service - Maningrida
Recruitment hospital [10] 0 0
Milikapiti Community Health Centre - Milikapiti
Recruitment hospital [11] 0 0
Milingimbi Health Clinic - Milingimbi
Recruitment hospital [12] 0 0
Minjilang Community Health Centre - Minjilang
Recruitment hospital [13] 0 0
Nauiyu - Nauiyu
Recruitment hospital [14] 0 0
Palumpa Community Health Centre - Palumpa
Recruitment hospital [15] 0 0
Pirlangimpi Health Clinic - Pirlangimpi
Recruitment hospital [16] 0 0
Ti Tree Community Health Centre - Ti Tree
Recruitment hospital [17] 0 0
Wadeye Community Health Centre - Wadeye
Recruitment hospital [18] 0 0
Warruwi Community Health Centre - Warruwi
Recruitment hospital [19] 0 0
Julanimawu (Nguiu) Community Health centre - Wurrumiyanga
Recruitment hospital [20] 0 0
Yirrkala Clinic - Yirrkala
Recruitment postcode(s) [1] 0 0
- Ali Curung
Recruitment postcode(s) [2] 0 0
- Ampilatwatja
Recruitment postcode(s) [3] 0 0
0800 - Darwin
Recruitment postcode(s) [4] 0 0
- Galiwin'ku
Recruitment postcode(s) [5] 0 0
- Gunbalanya
Recruitment postcode(s) [6] 0 0
0852 - Kalkarindji
Recruitment postcode(s) [7] 0 0
0850 - Katherine
Recruitment postcode(s) [8] 0 0
- Lajamanu
Recruitment postcode(s) [9] 0 0
0820 - Maningrida
Recruitment postcode(s) [10] 0 0
- Milikapiti
Recruitment postcode(s) [11] 0 0
0822 - Milingimbi
Recruitment postcode(s) [12] 0 0
- Minjilang
Recruitment postcode(s) [13] 0 0
- Nauiyu
Recruitment postcode(s) [14] 0 0
0822 - Palumpa
Recruitment postcode(s) [15] 0 0
0822 - Pirlangimpi
Recruitment postcode(s) [16] 0 0
0872 - Ti Tree
Recruitment postcode(s) [17] 0 0
0822 - Wadeye
Recruitment postcode(s) [18] 0 0
0822 - Warruwi
Recruitment postcode(s) [19] 0 0
0822 - Wurrumiyanga
Recruitment postcode(s) [20] 0 0
0880 - Yirrkala

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/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