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Trial registered on ANZCTR
Registration number
ACTRN12611000242921
Ethics application status
Approved
Date submitted
24/02/2011
Date registered
4/03/2011
Date last updated
20/10/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility study on the modification of drinking and safety behaviour through the use of participant designed, self generated text messages via mobile phones delivered at times scheduled by the participant
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Scientific title
In people aged 18 or over, do self-designed and self-scheduled text messages delivered via a web application to their phones prompt safer drinking practices while they are out socialising with friends?
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Secondary ID [1]
253533
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Nil
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Universal Trial Number (UTN)
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Trial acronym
SPILL IT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unintended negative consequences due to alcohol intoxication or impairment
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Excessive drinking to intoxication
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Condition category
Condition code
Public Health
259229
259229
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0
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Health promotion/education
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Injuries and Accidents
259334
259334
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will have 6 month access to a web site which allows them to generate text for their own messages. Participants will also determine when the messages will be sent to their mobile phone. The frequency of use of the web site and messaging is at the participants own discretion. They are the most qualified to determine when they will need a prompt to consider their safety and drinking behaviour. The control group will have 3 months access to the web site messaging. This is a feasibility study. The researchers do not wish to lead the participants regarding message content or frequency. The web site will provide instructions on how to use the messaging but no suggestions for message content. At the end of three months, both the intervention and control groups will have access to the intervention. This is to assess longevity of use and engagement with the web site.
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Intervention code [1]
257961
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Behaviour
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Intervention code [2]
264164
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Prevention
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Comparator / control treatment
Control treatment is 3 months access to a web site which has a community chat page and instructions on how to use the pending messaging option. This is the same web site that the intervention group will access but the message function will be hidden from the Control group. At the end of 3 months the control group will be given access to the message component.
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Control group
Active
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Outcomes
Primary outcome [1]
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Reduction in unintended negative consequences as measured by Young Adult Alcohol Problem Severity Test
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Assessment method [1]
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Timepoint [1]
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3 months & 6 months
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Secondary outcome [1]
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Reduction in number of drinks consumed during a drinking session as measured by AUDIT-C
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Assessment method [1]
273076
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Timepoint [1]
273076
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3 months & 6 months
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Eligibility
Key inclusion criteria
Participants must be within the age limits defined below and own a mobile phone.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No mobile phone or outside the specified age limit
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will access the web site and be provided with study information, click to agree to participate, fill in demographic data, drinking (AUDIT-C) and consequences (YAAPST) questions. They will then be computer assigned to a intervention or control group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3166
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New Zealand
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State/province [1]
3166
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Auckland
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Funding & Sponsors
Funding source category [1]
258486
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Self funded/Unfunded
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Name [1]
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Address [1]
258486
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Country [1]
258486
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New Zealand
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Primary sponsor type
Individual
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Name
Karen Renner
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Address
General Practice & Primary Health Care
School of Population Health
University of Auckland
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
257627
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Country [1]
257627
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260462
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Central Ethics Committee
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Ethics committee address [1]
260462
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Ethics Committees
Health and Disability Services Policy
Population Health Directorate
Ministry of Health
PO Box 5013
Wellington 6011
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Ethics committee country [1]
260462
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New Zealand
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Date submitted for ethics approval [1]
260462
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01/02/2011
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Approval date [1]
260462
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01/03/2011
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Ethics approval number [1]
260462
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CEN/11/03/010
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Summary
Brief summary
SPILL IT is a small study which aims to assess whether young drinkers (aged 18-34) would use a web site which helps them to get reminders on their mobile phones to keep safe while drinking. To ensure the safety messages are relevant, the young drinkers will write their own message and set the date and time when the message is sent to their phone. The reason for this is that plans to keep safe during drinking are forgotten when they have had a few drinks and are interacting with friends. A text message to their phone, while they are drinking, may remind them of their plans and therefore stop them getting hurt.
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Trial website
www.spillitnz.co.nz
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Trial related presentations / publications
Harm Reduction Text Messages Delivered During Alcohol Drinking: Feasibility Study Protocol Karen Adell Renner; Natalie Walker; Varsha Parag; Ross McCormick. JMIR Research Protocols 23.5.2012
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Karen Renner
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Address
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General Practice & Primary Health,
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+(64) 9 923 9170
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Natalie Walker
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Address
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Clinical Trials Research Unit
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+(64) 9 373 7599 x 89884
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Fax
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Email
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[email protected]
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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.
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