Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000123448
Ethics application status
Approved
Date submitted
20/11/2006
Date registered
12/02/2007
Date last updated
12/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alcohol Action in Rural Communities
Scientific title
A randomised control trial to evaluate the effects of a community-wide approach (including health, law enforcement and education groups) on reducing alcohol-related problems in rural communities in NSW.
Universal Trial Number (UTN)
Trial acronym
AARC-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol-related problems in rural communities in NSW 1615 0
Condition category
Condition code
Public Health 1723 1723 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial compares a systematic, community-wide approach to reducing alcohol-related problems (including health, police, legal and education groups) in experimental communities, versus 'usual practice' in matched control communities. The intervention will comprise a number of simultaneously implemented strategies over a three to four year period, including feedback of alcohol-related information via local media, high school education sessions, GP training in brief intervention, vocational programs targeting high-risk individuals and hospital-based alcohol interventions.
Intervention code [1] 1452 0
Other interventions
Comparator / control treatment
The control communities will continue to implement their existing programs (treatment as usual), but will not recieve the strategic, community-wide approach.
Control group
Active

Outcomes
Primary outcome [1] 2391 0
Reductions in alcohol-related criminal incidents
Timepoint [1] 2391 0
These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.
Primary outcome [2] 2392 0
Reductions in alcohol-related traffic accidents
Timepoint [2] 2392 0
These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.
Primary outcome [3] 2393 0
Reductions in alcohol-related emergency department presentations
Timepoint [3] 2393 0
These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.
Primary outcome [4] 2394 0
Reductions in alcohol-related hospital inpatient admissions.
Timepoint [4] 2394 0
These will be measured on an ongoing basis through daily routine data collection systems and analysed and reported back to the communities at least annually during the 3 year intervention period.
Secondary outcome [1] 4157 0
Process measures including documented changes in health services delivery, policing, legal referral practices and education-based prevention.
Timepoint [1] 4157 0
These will be measured at the time the relevant intervention strategy is implemented on a pre- and post-test basis only (ie: they will not be measured on an ongoing basis in the same way that the primary outcomes will be).

Eligibility
Key inclusion criteria
Communities must be in NSW; have a population size between 8,000 and 20,000
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Communities must be more than 70km from a major urban or regional centre; experimental and control communities must be at least 100km apart; and communities must not be involved in any other community-wide intervention studies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Twenty rural communities in NSW met all inclusion/exclusion criteria. Random allocation to experimental or control was done centrally by a statistician not involved in selecting communities
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible communities were stratified into matched pairs (based on age, sex and Indigenous characteristics) and one of each matched pair was allocated to the experimental condition by simple computer random number generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
31/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1872 0
Charities/Societies/Foundations
Name [1] 1872 0
Alcohol Education and Rehabilitation Foundation Ltd
Country [1] 1872 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 1687 0
University
Name [1] 1687 0
The University of NSW, National Drug and Alcohol Research Centre
Address [1] 1687 0
Country [1] 1687 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3480 0
University of Newcastle HREC-Corowa
Ethics committee address [1] 3480 0
Ethics committee country [1] 3480 0
Australia
Date submitted for ethics approval [1] 3480 0
Approval date [1] 3480 0
10/03/2004
Ethics approval number [1] 3480 0
H-752-0204
Ethics committee name [2] 3481 0
University of Newcastle HREC-Forbes
Ethics committee address [2] 3481 0
Ethics committee country [2] 3481 0
Australia
Date submitted for ethics approval [2] 3481 0
Approval date [2] 3481 0
10/03/2004
Ethics approval number [2] 3481 0
H-752-0204
Ethics committee name [3] 3482 0
University of Newcastle HREC-Grafton
Ethics committee address [3] 3482 0
Ethics committee country [3] 3482 0
Australia
Date submitted for ethics approval [3] 3482 0
Approval date [3] 3482 0
10/03/2004
Ethics approval number [3] 3482 0
H-752-0204
Ethics committee name [4] 3483 0
University of Newcastle HREC-Griffith
Ethics committee address [4] 3483 0
Ethics committee country [4] 3483 0
Australia
Date submitted for ethics approval [4] 3483 0
Approval date [4] 3483 0
10/03/2004
Ethics approval number [4] 3483 0
H-752-0204
Ethics committee name [5] 3484 0
University of Newcastle HREC-Gunnedah
Ethics committee address [5] 3484 0
Ethics committee country [5] 3484 0
Australia
Date submitted for ethics approval [5] 3484 0
Approval date [5] 3484 0
10/03/2004
Ethics approval number [5] 3484 0
H-752-0204
Ethics committee name [6] 3485 0
University of Newcastle HREC-Inverell
Ethics committee address [6] 3485 0
Ethics committee country [6] 3485 0
Australia
Date submitted for ethics approval [6] 3485 0
Approval date [6] 3485 0
10/03/2004
Ethics approval number [6] 3485 0
H-752-0204
Ethics committee name [7] 3486 0
University of Newcastle HREC-Kempsey
Ethics committee address [7] 3486 0
Ethics committee country [7] 3486 0
Australia
Date submitted for ethics approval [7] 3486 0
Approval date [7] 3486 0
10/03/2004
Ethics approval number [7] 3486 0
H-752-0204
Ethics committee name [8] 3487 0
University of Newcastle HREC-Leeton
Ethics committee address [8] 3487 0
Ethics committee country [8] 3487 0
Australia
Date submitted for ethics approval [8] 3487 0
Approval date [8] 3487 0
10/03/2004
Ethics approval number [8] 3487 0
H-752-0204
Ethics committee name [9] 3488 0
University of Newcastle HREC-Parkes
Ethics committee address [9] 3488 0
Ethics committee country [9] 3488 0
Australia
Date submitted for ethics approval [9] 3488 0
Approval date [9] 3488 0
10/03/2004
Ethics approval number [9] 3488 0
H-752-0204
Ethics committee name [10] 3489 0
University of Newcastle HREC-Tumut
Ethics committee address [10] 3489 0
Ethics committee country [10] 3489 0
Australia
Date submitted for ethics approval [10] 3489 0
Approval date [10] 3489 0
10/03/2004
Ethics approval number [10] 3489 0
H-752-0204

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

Contacts
Principal investigator
Name 27386 0
Address 27386 0
Country 27386 0
Phone 27386 0
Fax 27386 0
Email 27386 0
Contact person for public queries
Name 10641 0
Dr Anthony Shakeshaft
Address 10641 0
National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052
Country 10641 0
Australia
Phone 10641 0
+61 2 93850285
Fax 10641 0
+61 2 93850222
Email 10641 0
[email protected]
Contact person for scientific queries
Name 1569 0
Dr Anthony Shakeshaft
Address 1569 0
National Drug and Alcohol Research Centre
University of NSW
Sydney NSW 2052
Country 1569 0
Australia
Phone 1569 0
+61 2 93850285
Fax 1569 0
+61 2 93850222
Email 1569 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

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

Documents added automatically
No additional documents have been identified.