Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000075684
Ethics application status
Approved
Date submitted
10/01/2014
Date registered
22/01/2014
Date last updated
22/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Shhh hearing in a farming environment - reducing noise exposures and the impact of hearing loss on farmers and their families
Scientific title
Shhh hearing in a farming environment - Effect of on-farm noise audits and the Montreal Health Hearing Program (MHHP) on reducing noise exposures and the impact of hearing loss on farmers and their families.
Secondary ID [1] 283811 0
Nil
Universal Trial Number (UTN)
U1111-1151-5688
Trial acronym
Shhh hearing in a farming environment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 290789 0
Condition category
Condition code
Ear 291157 291157 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred farming participants (with self-reported hearing problems) will be allocated to either (a) the intervention group (N=50), in which they will receive the Montreal Health Hearing Program (MHHP) via a workshop, an on farm noise audit, and a follow up workshop or (b) the control group (N=50). Outcomes for each group will be tracked from pre-intervention to six month follow-up.

The MHHP will be delivered by Health Professionals trained in the MHHP and experienced in working with farming populations to the intervention group of farm men and women in addition to on-farm noise audits. The MHHP will occur over two days in 2 x 4 hour sessions in the participant’s local community. The first workshop will occur at the beginning of the intervention and the second workshop 6 months later.

The on-farm noise audit will be undertaken at the beginning of the intervention. Field measurements will be carried out by trained health professionals using a CEL–244 digital integrating Sound Level Meter, for the direct noise measurement for sampled farm activities and CEL-350/K4 dBadge personal noise exposure dosimeters in accordance with the measurement and calibration procedures provided in AS/NZS 1269.1: 2005.
Intervention code [1] 288499 0
Prevention
Intervention code [2] 288618 0
Behaviour
Intervention code [3] 288619 0
Rehabilitation
Comparator / control treatment
Farming participants allocated to the control group will not receive any workshop intervention (MHHP) from the research team. Data will be collected at baseline and 6 months. Control group will be offered an on-farm noise audit and sent an information booklet on easier listening. Allocation will occur at an geographical level. This design will be a partial single blind study, in which participants are unaware of interventions being implemented other than in their own setting.
Control group
Active

Outcomes
Primary outcome [1] 291144 0
Reduction in the impact of hearing loss on farmers and their families.
Change will be assessed using pre and post survey tools measuring the social impact of hearing loss and mental health.
Timepoint [1] 291144 0
At the commencement of the intervention and 6- 8 months following the intervention change will be assessed on both the individual and partner/ family member using tools (surveys, focus groups and action plans).

Mental health assessment
The DASS-21, made up of three seven-item subscales that measure the three dimensions specified in Lovibond and Lovibond’s (1995a) tripartite model of affect: low positive affect (Depression), physiological hyperarousal (Anxiety), and negative affect (Stress).
Primary outcome [2] 291145 0
Farming participants capacity to reduce their noise exposure has increased.
This will be measured following on-farm noise audit and completion of the workshops.
Timepoint [2] 291145 0
At the commencement of the intervention and at 6-8 months (following completion of the final workshop) using tools (surveys, focus groups and particpant action plans).
Secondary outcome [1] 306131 0
Registered nurses working with farm men and women are trained in the Montreal Health Hearing Program (MHHP) and have increased knowledge of hearing problems and are able to recognise symptoms of hearing loss including personal and social reactions and responses. Participating health providers will complete pre and post training surveys to assess
1. Knowledge of hearing problems and their
2. Understanding of the social impact of noise induced hearing loss
Timepoint [1] 306131 0
Prior to commencement of the MHHP training and at completion of the program.

Eligibility
Key inclusion criteria
Are over the age of 20 years and under the age of 78;
Are currently farming;
Speak English;
Are competent to decide and have capacity to consent to participate, attend health hearing workshops and health assessment, and be interviewed as a member of a focus group.
Have self reported hearing loss
Minimum age
20 Years
Maximum age
78 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
non farmers

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
4/03/2012
Date of last participant enrolment
Anticipated
30/03/2013
Actual
13/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 1980 0
Western District Health Service - Hamilton - Hamilton
Recruitment postcode(s) [1] 7689 0
3300 - Hamilton
Recruitment postcode(s) [2] 7690 0
3632 - Shepparton
Recruitment postcode(s) [3] 7691 0
3250 - Colac
Recruitment postcode(s) [4] 7693 0
3377 - Ararat
Recruitment postcode(s) [5] 7694 0
3669 - Violet Town
Recruitment postcode(s) [6] 7695 0
4606 - Wondai
Recruitment postcode(s) [7] 7696 0
3311 - Casterton

Funding & Sponsors
Funding source category [1] 288532 0
Government body
Name [1] 288532 0
National Health and Medical Research Council (NHMRC)
Country [1] 288532 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
75 Pigdons Rd,
Waurn Ponds.
3216 VIC
Country
Australia
Secondary sponsor category [1] 287242 0
University
Name [1] 287242 0
University of Canberra
Address [1] 287242 0
University Dr,
Bruce ACT 2617
Country [1] 287242 0
Australia
Secondary sponsor category [2] 287243 0
Other Collaborative groups
Name [2] 287243 0
National Accoustic Laboratories
Address [2] 287243 0
Australian Hearing Hub,
16 University Ave,
Macquarie Park NSW 2113
Country [2] 287243 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290397 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 290397 0
Ethics committee country [1] 290397 0
Australia
Date submitted for ethics approval [1] 290397 0
Approval date [1] 290397 0
24/02/2012
Ethics approval number [1] 290397 0
2012-006

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

Contacts
Principal investigator
Name 45150 0
A/Prof Susan Brumby
Address 45150 0
National Centre for Farmer Health
Western District Health Service,
Tyers Street,
Hamilton. VIC 3300
Country 45150 0
Australia
Phone 45150 0
+61 3 55518460
Fax 45150 0
Email 45150 0
[email protected]
Contact person for public queries
Name 45151 0
Susan Brumby
Address 45151 0
National Centre for Farmer Health
Western District Health Service,
Tyers Street,
Hamilton. VIC 3300
Country 45151 0
Australia
Phone 45151 0
+61 3 55518460
Fax 45151 0
Email 45151 0
[email protected]
Contact person for scientific queries
Name 45152 0
Anthony Hogan
Address 45152 0
University of Canberra,
University Drive,
Bruce. ACT 2161
Country 45152 0
Australia
Phone 45152 0
61 2 62015213
Fax 45152 0
Email 45152 0
[email protected]

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

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