Trial from ANZCTR


Trial ID ACTRN12612001220853
Trial Status: Registered
Date Submitted: 8/11/2012
Date Registered: 19/11/2012
Retrospectively registered

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Public title YourCall Study: The effectiveness of text messaging to address hazardous drinking among trauma patients
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format YourCall Study:The effectiveness of text messaging to address hazardous drinking behaviours among admitted trauma patients
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Secondary ID [1] 281512 0
Nil
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UTN U1111-1134-0028
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Trial acronym
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Health condition(s) or problem(s) studied:
Hazardous alcohol use 287780 0
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Injuries 287781 0
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Condition category: Condition code:
Injuries and Accidents Other injuries and accidents
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288131 288131 0 0
Public Health Health promotion/education
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Descriptions of intervention(s) / exposure A novel mobile-phone delivered text message intervention consisting of 16 text messages in total sent over one month, with one message sent every 2 days. Participants will receive similar text message content and will have the option of receiving text messasges in a)English, b) English with some Te Reo Maori words of greeting and encouragement, c) Te Reo Maori, or d) English with a Pacific language greeting.
The text message programme is based on Brief Intervention for Harm guidelines and behaviour change theory and consists of supportive, motivational and informative messages aimed at reducing alcohol consumption and alcohol-related harm.
Eligible trauma patients will be screened using the 10 question Alcohol Use Disorders Identification Test (AUDIT) questionnaire. Those with AUDIT scores 7-15 for women and 8-15 for men will be eligible to take part in the trial.
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Intervention Code:
Prevention 286029 0
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Intervention Code:
Behaviour 286076 0
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Comparator / control treatment The control group will receive ‘usual care’ i.e. they will receive interventions/referrals (for hazardous alcohol use) that they would normally receive from their hospital Clinical Teams. They will also receive an alcohol brochure from the Research Team.
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Control group Active
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Primary Outcome: Change in problem drinking at 3 months follow-up assessed using the AUDIT-C tool via mobile phone text messaging 288331 0
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Timepoint: 3 months 288331 0
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Secondary Outcome: Medically attended injuries obtained by probabilistic record linkage to national databases 299888 0
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Timepoint: 12 months 299888 0
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Secondary Outcome: Self-reported alcohol-related health and social harms obtained through an online self-completed questionnaire. 299889 0
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Timepoint: 12 months 299889 0
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Key inclusion criteria Admission for an injury-related cause to one of three trauma admitting hospitals in the Auckland Region
Competent to provide informed consent
Drink alcohol
Own/use a mobile phone, which is not shared with another person
Willing and able to read and send text message
Able to complete surveys in English
Are to be discharged to their home
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Minimum age 16 Years
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Maximum age 69 Years
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Pregnant
Visitor to New Zealand
Injury is self-harm
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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)
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded (choose all that apply)


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Assignment
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Other design features
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Phase
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Anticipated date of first participant enrolment 9/11/2012
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Date of first participant enrolment 9/11/2012
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 19/12/2013
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Target sample size 570
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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

Country: New Zealand 4672 0
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State/Province: 4672 0
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Funding Source: Government body 286292 0
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Name: Health Research Council of New Zealand 286292 0
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Address: Level 3, 110 Stanley St
PO Box 5541
Wellesley St
Auckland 1141
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Country: New Zealand 286292 0
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Primary Sponsor University
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Name: The University of Auckland
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Address: The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
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Country: New Zealand
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Secondary Sponsor: None 285085 0
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Name: 285085 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Northern B Health and Disability Ethics Committee 288367 0
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Address: 288367 0
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Country: New Zealand 288367 0
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Approval Date: 17/10/2012 288367 0
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Submitted Date: 288367 0
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HREC: 288367 0
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Brief summary In New Zealand and internationally, missed opportunities in the healthcare system to identify and reduce hazardous drinking among high-risk patients are very common. We have developed a mobile-phone text message programme (‘YourCall’) based on Brief Intervention for Harm guidelines and behaviour change theory, which is aimed at reducing alcohol consumption and alcohol-related harm. The text messages consist of supportive, motivational, and informative messages developed with input from experts in mobile phone health technology, drug and alcohol clinical services, health psychology, and Maori, Pacific, and Asian Health. The goal of this research is to evaluate the mobile-phone text message intervention among trauma patients aged 16 to 60 years admitted to hospital who screen positive for hazardous alcohol use.

We will screen trauma patients for hazardous alcohol use (using the 10 question Alcohol Use Disorders Identification Test [AUDIT] questionnaire) and carry out a randomised controlled trial to investigate the effectiveness of the text message intervention. The study will compare a group of patients who receive the text messages to a control group who receive usual care. Our primary outcome of interest is reduction in alcohol misuse (measured using the three-question AUDIT-C survey) at 3 months. The effects will be reviewed at 6, 9 and 12 months. Through record linkage to hospital discharge, mortality and Accident Compensation Corporation data, we will also investigate the impact on further injuries and other harms. This patient-centred intervention has the potential to be cost-effective, highly scalable and accessible to harder-to-reach communities, including youth and economically disadvantaged groups.
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Trial website
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Public Notes
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Principal Investigator
Title: Prof
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Name: Shanthi Ameratunga
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Address: Section of Epidemiology and Biostatistics School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
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Country: New Zealand
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Tel: +64 9 923 6354
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Email: s.ameratunga@auckland.ac.nz
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Contact person for public queries
Title: Dr
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Name: Dr Sarah Sharpe
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Address: Section of Epidemiology and Biostatistics School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
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Tel: +64 9 923 3371
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Email: s.sharpe@auckland.ac.nz
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Contact person for scientific queries
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Name: Professor Shanthi Ameratunga
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Address: Section of Epidemiology and Biostatistics School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
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Country: New Zealand
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Email: s.ameratunga@auckland.ac.nz
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Contact person responsible for updating information
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Name: Dr Sarah Sharpe
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Address: Section of Epidemiology and Biostatistics School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
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Country: New Zealand
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Addition Cancer fields
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