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Trial registered on ANZCTR


Registration number
ACTRN12612001206819
Ethics application status
Approved
Date submitted
14/11/2012
Date registered
15/11/2012
Date last updated
15/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of multi-level interventions to promote the use of hearing protection behaviour.
Scientific title
The use of multi-level interventions to promote the use of hearing protection devices amongst manufacturing workers in New Zealand.
Secondary ID [1] 281537 0
Nil
Universal Trial Number (UTN)
U1111-1137-0101
Trial acronym
Noise Induced Hearing Loss
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Noise Induced Hearing Loss 287801 0
Condition category
Condition code
Ear 288152 288152 0 0
Deafness
Public Health 288153 288153 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Training programme: The training programme is a 30 to 40 minute interactive health communication presentation using various modalities such as observation, hands-on, demonstration and activities. The training is around key components of hearing protection, hearing science and best practice. In its basic form, it includes a 'booster' two months after training: this involves texting one key training message a day for 5 days. The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention. In addition, we will briefly interview the employers and foreman/supervisor after four months to ask them if they have observed any behaviour change towards hearing protection in their workers.
Arm 2 - Training programme without 2-month booster: The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention. In addition, we will briefly interview the employers and foreman/supervisor after four months to ask them if they have observed any behaviour change towards hearing protection in their workers.
Arm 3 - Training programme with booster + Class 5 active earmuffs: Active listening devices are electronic earmuffs powered by 2 AA batteries that allow for face to face communication without the need to remove earmuffs. Intervention 3 adds these to the basic training which includes booster. The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention. In addition, we will briefly interview the employers and foreman/supervisor after four months to ask them if they have observed any behaviour change towards hearing protection in their workers.
Intervention code [1] 286050 0
Behaviour
Comparator / control treatment
The control group will not receive any intervention but will be offered the training programme on completion of the study. The evaluation timeline begins with one measure on consent to participate, then at one week, two months, and four months after intervention.
Control group
Active

Outcomes
Primary outcome [1] 288355 0
Percentage of workers reporting to always use hearing protection devices when exposed to noise. Self assessment quesitonnaire will be used to speicfy this outcome.
Timepoint [1] 288355 0
The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention.
Primary outcome [2] 288356 0
Supports to barrier ratio using Hearing Protection Assessment 5 scale questionnaire (HPA 5).
Timepoint [2] 288356 0
The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention.
Secondary outcome [1] 299941 0
Noise and hearing loss knowledge scale
Timepoint [1] 299941 0
The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention.
Secondary outcome [2] 299942 0
Noise, hearing loss & hearing protection attitude scale
Timepoint [2] 299942 0
The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention.
Secondary outcome [3] 299943 0
Hearing protection behaviour scale
Timepoint [3] 299943 0
The evaluation timeline begins with one measure prior to training, then at one week, two months, and four months after intervention.

Eligibility
Key inclusion criteria
Workers working in the manufacturing industry and noisy environments (>85dBA).
Units in the Manufacturing Division are often described as plants, factories or mills and characteristically use power-driven machines and other materials-handling equipment.
Companies defined as small enterprise (<20).
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Workers who do not work in the manufacturing industry and workers who do not work in noisy working environments (85dBA).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will approach small enterprises which took part in Phase 2 of the research to take part in this study; where insufficient numbers are obtained, more small enterprises will be convenience sampled using the telephone directory. The companies will be randomly assigned, by computer, to any one of the four groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer. (Excel)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4680 0
New Zealand
State/province [1] 4680 0
Auckland

Funding & Sponsors
Funding source category [1] 286317 0
Government body
Name [1] 286317 0
Health Research Council of New Zealand, Accident Compensation Corporation (ACC) Doctoral Award
Country [1] 286317 0
New Zealand
Primary sponsor type
Individual
Name
Ravi Reddy
Address
Section of Audiology, School of Population Health, Tamaki Campus, University of Auckland, 261 Morrin Road, Glen Innes, Auckland 1072.
Country
New Zealand
Secondary sponsor category [1] 285103 0
Individual
Name [1] 285103 0
Dr David Welch
Address [1] 285103 0
Section of Audiology, School of Population Health, Tamaki Campus, 261 Morrin Road, Glen Innes, University of Auckland, Auckland 1072.
Country [1] 285103 0
New Zealand
Other collaborator category [1] 277172 0
Individual
Name [1] 277172 0
Professor Shanthi Ameratunga
Address [1] 277172 0
School of Population Health, Tamaki Campus, University of Auckland, 261 Morrin Road, Glen Innes, Auckland 1072.
Country [1] 277172 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288387 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 288387 0
Ethics committee country [1] 288387 0
New Zealand
Date submitted for ethics approval [1] 288387 0
Approval date [1] 288387 0
09/11/2012
Ethics approval number [1] 288387 0
2010/214

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34949 0
Address 34949 0
Country 34949 0
Phone 34949 0
Fax 34949 0
Email 34949 0
Contact person for public queries
Name 18196 0
Ravi Reddy
Address 18196 0
Section of Audiology,
Tamaki Innovation Campus,
School of Population Health,
University of Auckland,
261 Morrin Road,
Glen Innes,
Auckland 1072.
Country 18196 0
New Zealand
Phone 18196 0
+64 9 3737599
Fax 18196 0
Email 18196 0
r.reddy@auckland.ac.nz
Contact person for scientific queries
Name 9124 0
Ravi Reddy
Address 9124 0
Section of Audiology,
Tamaki Innovation Campus,
School of Population Health,
University of Auckland,
261 Morrin Road,
Glen Innes,
Auckland 1072.
Country 9124 0
New Zealand
Phone 9124 0
+64 9 3737599
Fax 9124 0
Email 9124 0
r.reddy@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.