Trial from ANZCTR


Trial ID ACTRN12607000123448
Trial Status: Registered
Date Submitted: 20/11/2006
Date Registered: 12/02/2007
Retrospectively registered

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Public title Alcohol Action in Rural Communities
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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UTN
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Trial acronym AARC-RCT
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Health condition(s) or problem(s) studied:
Alcohol-related problems in rural communities in NSW 1615 0
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Public Health Other public health
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1723 1723 0 0

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Descriptions 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.
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Intervention Code:
Other interventions 1452 0
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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.
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Control group Active
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Primary Outcome: Reductions in alcohol-related criminal incidents 2391 0
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Timepoint: 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. 2391 0
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Primary Outcome: Reductions in alcohol-related traffic accidents 2392 0
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Timepoint: 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. 2392 0
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Primary Outcome: Reductions in alcohol-related emergency department presentations 2393 0
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Timepoint: 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. 2393 0
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Primary Outcome: Reductions in alcohol-related hospital inpatient admissions. 2394 0
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Timepoint: 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. 2394 0
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Secondary Outcome: Process measures including documented changes in health services delivery, policing, legal referral practices and education-based prevention. 4157 0
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Timepoint: 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). 4157 0
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Key inclusion criteria Communities must be in NSW; have a population size between 8,000 and 20,000
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Minimum age No limit
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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
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Describe the 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
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 2 / Phase 3
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Anticipated date of first participant enrolment 31/12/2004
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 20
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 1872 0
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Name: Alcohol Education and Rehabilitation Foundation Ltd 1872 0
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Address: 1872 0
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Country: Australia 1872 0
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Primary Sponsor University
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Name: The University of Newcastle
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Country: Australia
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Secondary Sponsor: University 1687 0
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Name: The University of NSW, National Drug and Alcohol Research Centre 1687 0
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Address: 1687 0
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Country: Australia 1687 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Newcastle HREC-Corowa 3480 0
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Country: Australia 3480 0
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Approval Date: 10/03/2004 3480 0
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Submitted Date: 3480 0
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HREC: H-752-0204 3480 0
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Ethics Committee name: University of Newcastle HREC-Forbes 3481 0
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Country: Australia 3481 0
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Ethics Committee name: University of Newcastle HREC-Grafton 3482 0
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Ethics Committee name: University of Newcastle HREC-Griffith 3483 0
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Ethics Committee name: University of Newcastle HREC-Gunnedah 3484 0
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Ethics Committee name: University of Newcastle HREC-Inverell 3485 0
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Country: Australia 3485 0
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Ethics Committee name: University of Newcastle HREC-Kempsey 3486 0
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Ethics Committee name: University of Newcastle HREC-Leeton 3487 0
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Ethics Committee name: University of Newcastle HREC-Parkes 3488 0
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Ethics Committee name: University of Newcastle HREC-Tumut 3489 0
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Brief summary The primary purpose of the sudy is to reduce alcohol-related problems in selected rural communities in NSW by sytematically implementing a number of interventions across the whole community, involving numerous community groups, such as schools, police, health workers, GPs and road safety officers. It is anticipated that the communities involved in this process will reduce their number of alcohol-related problems by more than similar communities that are not involved in this process.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Anthony Shakeshaft
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Address: National Drug and Alcohol Research Centre University of NSW Sydney NSW 2052
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Country: Australia
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Tel: +61 2 93850285
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Fax: +61 2 93850222
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Email: a.shakeshaft@unsw.edu.au
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Contact person for scientific queries
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Name: Dr Anthony Shakeshaft
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Address: National Drug and Alcohol Research Centre University of NSW Sydney NSW 2052
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