Trial from ANZCTR


Trial ID ACTRN12607000103460
Trial Status: Registered
Date Submitted: 8/09/2006
Date Registered: 31/01/2007
Retrospectively registered

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Public title A randomised controlled trial of a primary care-based electronic screening and brief intervention for hazardous drinking
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial to evaluate the effects of web-based motivational feedback on hazardous drinking for the prevention of alcohol-related harm in healthy participants
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Harmful alcohol consumption in healthy participants 1597 0
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Public Health Health promotion/education
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1700 1700 0 0

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Descriptions of intervention(s) / exposure B: Screening (The screening involves patients to complete the 10-item Alcohol Use Disorders Identification Test (AUDIT) at a computer in the waiting area which is connected to the Internet. They also answered questions about the largest amount they consumed in a single episode in the last 4 weeks, the duration of the episode, their age, gender, and ethnicity. It takes 3 minutes.), information leaflet (An educational leaflet providing information on the effects of alcohol and recommended upper limits for low-risk consumption) plus assessment of alcohol use, perceptions of peer drinking norms, and problems 4 weeks later. The assessment involves a 14-day retrospective account of drinks per day, the Alcohol Problems Scale - 14 items, the Academic Role Expectations and Alcohol Scale - 5 items, estimates of others' drinking (7 items) and their height and weight. Median completion time is 11 minutes.
C: Web-based motivational intervention (single-dose); including comparison of patient's drinking with age/gender norms and recommended upper limits. This intervention takes 11 minutes to answer the questions (see above) plus the time required to read the feedback, which we estimate to be 3-5 minutes. Overall, total time is approximately 15 minutes.
D: Web-based motivational intervention (multi-dose); as in C, provided at the commencement of the trial, at 6 months and at 12 months. This intervention takes 15 minutes at baseline and a further 10 minutes four weeks later for assessment and feedback.
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Intervention Code:
Behaviour 1354 0
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Comparator / control treatment A: Screening and information leaflet (control). An educational leaflet providing information on the effects of alcohol and recommended upper limits for low-risk consumption. The screening involves patients to complete the 10-item Alcohol Use Disorders Identification Test (AUDIT) at a computer in the waiting area which is connected to the Internet. They also answered questions about the largest amount they consumed in a single episode in the last 4 weeks, the duration of the episode, their age, gender, and ethnicity. It takes 3 minutes.
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Control group Active
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Primary Outcome: Assessment by computer over the Internet of the Quantity and frequency of drinking 2357 0
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Timepoint: At 6 and 12 months. 2357 0
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Primary Outcome: Assessment by computer over the Internet of Binge Drinking. 2358 0
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Timepoint: At 6 and 12 months. 2358 0
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Primary Outcome: Assessment by computer over the Internet of Personal and Academic Problems. 2359 0
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Timepoint: At 6 and 12 months. 2359 0
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Primary Outcome: Assessment by computer over the Internet of the Alcohol Use Disorders Identification Test Score. 2360 0
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Timepoint: At 12 months. 2360 0
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Secondary Outcome: Change in normative perceptions 4112 0
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Timepoint: measured at 6 months and 12 months 4112 0
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Key inclusion criteria Patients of the University of Otago Student Health Service, Sufficient English to understand consent form
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Minimum age 17 Years
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Maximum age 29 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria If too sick or injured to participate
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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) Research staff involved in the trial were not informed of participants’ group allocation during intervention or follow-up. The generation of the sequence and loading of it into the server database were conducted by off-site staff who were not involved in the implementation of the trial on site, who never came into contact with study participants. Participants were informed that they were participating in a series of surveys about their drinking. Thier perceptions were checked in a pilot study, and found to be consistent with the aim to conceal group allocation.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) The random sequence was generated in Microsoft Excel using the rand function, and this was loaded into the server which administered the intervention.
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Masking / blinding Blinded (masking 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 Subjects were blind. Note: there were no assessors or therapists as such: all done by computer. The intervention, assessment, and analysis may therefore be said to have been conducted blindly.
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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 3/03/2003
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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 572
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 1843 0
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Name: Health Research Council of New Zealand 1843 0
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Address: 1843 0
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Country: New Zealand 1843 0
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Funding Source: Government body 1844 0
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Name: Alcohol Advisory Council of New Zealand 1844 0
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Address: 1844 0
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Country: New Zealand 1844 0
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Primary Sponsor Individual
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Name: Dr Kypros Kypri
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Secondary Sponsor: None 1661 0
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Name: Nil 1661 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 Otago Student Health Service. 3445 0
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Address: 3445 0
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Country: New Zealand 3445 0
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Approval Date: 01/02/2002 3445 0
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Submitted Date: 3445 0
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HREC: 02/010. 3445 0
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Brief summary There is compelling evidence for the efficacy of screening and brief intervention (SBI) for hazardous drinking, yet it is not widely available in primary healthcare. Electronic (computer/web-based) intervention offers the prospect of ease, simplicity, and economy of access.
The objective was to examine whether electronic SBI (single- and multi-intervention) reduces hazardous drinking and related problems compared with an information leaflet alone (control condition).
Design and Setting: Randomized controlled trial at a university health service (enrolment 8/2003), with follow-up measures taken at 6 and 12 months.
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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 Kypros Kypri
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Address: School of Medicine and Public Health University of Newcastle David Maddison Building King & Watt Streets Newcastle NSW 2300
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Country: Australia
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Tel: +61 2 49236231
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Fax: +61 2 49236148
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Email: kypros.kypri@newcastle.edu.au
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Contact person for scientific queries
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Name: Dr Kypros Kypri
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Address: School of Medicine and Public Health University of Newcastle David Maddison Building King & Watt Streets Newcastle NSW 2300
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Country: Australia
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Email: kypros.kypri@newcastle.edu.au
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