close help
scroll up   scroll up
Australian New Zealand Clinical Trials Registry
Home Login Contact us Feedback
Australian New Zealand Clinical Trials Registry
Register Trial Trial Search Latest News FAQ About ANZCTR
ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

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

Page 1

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:

Page 2

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

Page 3

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

Page 4

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 

Page 5

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

Page 6
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

Page 7
Phase Phase 2 / Phase 3
Anticipated or actual start date: 3/03/2003
Target sample size: 572
Recruitment status: Closed: follow-up complete

Page 8

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: 

Page 9

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:

Page 10

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

Contact person responsible for updating information
Name:
Address:
Country:
Tel:
Fax:
Email:
   
© 2007 ANZCTR Terms and Conditions Privacy      Design by Symbiation