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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 081594
ACTR Number: ACTRN12607000103460
Trial Status: Registered
Date Submitted: 8/09/2006
Date Registered: 31/01/2007

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Public title: A randomised controlled trial of a primary care-based electronic screening and brief intervention for hazardous drinking
ANZCTR registration title: 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
Secondary ID: 
UTN:
Trial acronym:

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Health condition(s) or problem(s) studied:
Harmful alcohol consumption in healthy participants 
Condition category: Condition code:
Public Health Health promotion/education 

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Description 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.
Intervention code:Behaviour 
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.
Control group: Active

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Primary outcome 1:Assessment by computer over the Internet of the Quantity and frequency of drinking 
Timepoint:At 6 and 12 months. 
Primary outcome 2:Assessment by computer over the Internet of Binge Drinking. 
Timepoint:At 6 and 12 months. 
Primary outcome 3:Assessment by computer over the Internet of Personal and Academic Problems. 
Timepoint:At 6 and 12 months. 
Primary outcome 4:Assessment by computer over the Internet of the Alcohol Use Disorders Identification Test Score. 
Timepoint:At 12 months. 
Secondary outcome:Change in normative perceptions 
Timepoint:measured at 6 months and 12 months 

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Key inclusion criteria: Patients of the University of Otago Student Health Service, Sufficient English to understand consent form
Minimum Age: 17 Years
Maximum Age: 29 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: If too sick or injured to participate

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
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.
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.
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people receiving the treatment/s
 The people assessing the outcomes
 The people analysing the results/data
Assignment: Parallel
Other design features (specify): 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.
Type of endpoint(s): Efficacy

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Phase Phase 2 / Phase 3
Anticipated or actual date of first participant enrolement: 3/03/2003
Target sample size: 572
Recruitment status: Closed: follow-up complete

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Funding source 1:Government funding body e.g. Australian Research Council 
Name:Health Research Council of New Zealand 
Address: 
Country:New Zealand 
Funding source 2:Government funding body e.g. Australian Research Council 
Name:Alcohol Advisory Council of New Zealand 
Address: 
Country:New Zealand 
Primary sponsor: Individual
Name: Dr Kypros Kypri
Address:
Country:
Secondary sponsor:None 
Name:Nil 
Address: 
Country: 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:University of Otago Student Health Service. 
Address: 
Country:New Zealand 
Date of approval:1/02/2002 
HREC Number:02/010. 
Countries of recruitment:Australia 
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.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr Kypros Kypri
Address: School of Medicine and Public Health University of Newcastle David Maddison Building King & Watt Streets Newcastle NSW 2300
Country: Australia
Tel: +61 2 49236231
Fax: +61 2 49236148
Email: kypros.kypri@newcastle.edu.au

Contact person for scientific queries
Name: Dr Kypros Kypri
Address: School of Medicine and Public Health University of Newcastle David Maddison Building King & Watt Streets Newcastle NSW 2300
Country: Australia
Tel: +61 2 49236231
Fax: +61 2 49236148
Email: kypros.kypri@newcastle.edu.au

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