Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001220853
Ethics application status
Approved
Date submitted
8/11/2012
Date registered
19/11/2012
Date last updated
24/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
YourCall Study: The effectiveness of text messaging to address hazardous drinking among trauma patients
Scientific title
YourCall Study:The effectiveness of text messaging to address hazardous drinking behaviours among admitted trauma patients
Secondary ID [1] 281512 0
Nil
Universal Trial Number (UTN)
U1111-1134-0028
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hazardous alcohol use 287780 0
Injuries 287781 0
Condition category
Condition code
Injuries and Accidents 288131 288131 0 0
Other injuries and accidents
Public Health 288132 288132 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 286029 0
Prevention
Intervention code [2] 286076 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 288331 0
Change in problem drinking at 3 months follow-up assessed using the AUDIT-C tool via mobile phone text messaging
Timepoint [1] 288331 0
3 months
Secondary outcome [1] 299888 0
Medically attended injuries obtained by probabilistic record linkage to national databases
Timepoint [1] 299888 0
12 months
Secondary outcome [2] 299889 0
Self-reported alcohol-related health and social harms obtained through an online self-completed questionnaire.
Timepoint [2] 299889 0
12 months

Eligibility
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
Minimum age
16 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant
Visitor to New Zealand
Injury is self-harm

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/11/2012
Actual
9/11/2012
Date of last participant enrolment
Anticipated
Actual
19/12/2013
Date of last data collection
Anticipated
Actual
2/02/2015
Sample size
Target
570
Accrual to date
Final
598
Recruitment outside Australia
Country [1] 4672 0
New Zealand
State/province [1] 4672 0
Auckland

Funding & Sponsors
Funding source category [1] 286292 0
Government body
Name [1] 286292 0
Health Research Council of New Zealand
Country [1] 286292 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 285085 0
None
Name [1] 285085 0
Address [1] 285085 0
Country [1] 285085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288367 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 288367 0
Ethics committee country [1] 288367 0
New Zealand
Date submitted for ethics approval [1] 288367 0
Approval date [1] 288367 0
17/10/2012
Ethics approval number [1] 288367 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34931 0
Prof Shanthi Ameratunga
Address 34931 0
Section of Epidemiology and Biostatistics School of Population Health The University of Auckland Private Bag 92019 Auckland Mail Centre Auckland 1142
Country 34931 0
New Zealand
Phone 34931 0
+64 9 923 6354
Fax 34931 0
Email 34931 0
s.ameratunga@auckland.ac.nz
Contact person for public queries
Name 18178 0
Dr Dr Sarah Sharpe
Address 18178 0
Section of Epidemiology and Biostatistics
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 18178 0
New Zealand
Phone 18178 0
+64 9 923 3371
Fax 18178 0
Email 18178 0
s.sharpe@auckland.ac.nz
Contact person for scientific queries
Name 9106 0
Prof Professor Shanthi Ameratunga
Address 9106 0
Section of Epidemiology and Biostatistics
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 9106 0
New Zealand
Phone 9106 0
+64 9 923 6354
Fax 9106 0
Email 9106 0
s.ameratunga@auckland.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of the YourCallTM text message intervention to reduce harmful drinking in patients discharged from trauma wards: protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s12889-016-3967-z
EmbaseEffect of a text message intervention on alcohol-related harms and behaviours: secondary outcomes of a randomised controlled trial.2019https://dx.doi.org/10.1186/s13104-019-4308-y
N.B. These documents automatically identified may not have been verified by the study sponsor.