Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001395224
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
20/08/2018
Date last updated
20/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a text message brief intervention (BI) to reduce alcohol-related harm on the Plastic Surgery service at CMDHB
Scientific title
Reducing alcohol-related harm: Feasibility and effectiveness of a text message-based intervention delivered through the Plastic Surgery service
Secondary ID [1] 295114 0
Ni Known
Universal Trial Number (UTN)
U1111-1215-3247
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Alcohol use 308193 0
Condition category
Condition code
Public Health 307224 307224 0 0
Health promotion/education
Diet and Nutrition 307225 307225 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a web based, text messaged delivered BI to affect change in harmful drinking behaviour. Drinking behaviours and harms will be assessed by the validated Alcohol Use Disorders Identification Test (AUDIT) alcohol screening test as well as the brief version of the Young Adults Alcohol Related Consequences Questionnaire (B-YAARCQ) to assess and reduce alcohol-related harm. These will be administered on sign up, at 6 weeks and at 3 months following recruitment.
There are three arms to study:
The first arm gives access to the website questionnaires only ("Control arm").
The second arm delivered standardized text messages as a BI at pre-determined times ("Passive arm") weekly for six weeks.
The third arm delivered text messages designed by the participants ("Active arm") weekly for six weeks.
Participants will be approached (face-to-face) to enroll once admitted to the Plastic Surgery department at Middlemore hospital with an alcohol-related injury requiring treatment. Approach will be made by a non-surgical team member. Patients will be given a written information sheet about the trial. All other information in provided on line, via the customised SpillIt website. Randomisation will happen automatically by the website computerised randomization process once the patient signs up. A copy of the standardized text messages delivered to group two is attached as a separate document at the end of this application (called "my message schedule"). Participants in the third (active) arm will then have the opportunity to write their own personalised messages and determine the dates and times they will be delivered via text message to their phones. These participants are then given free reign ton type their own message (any wording, in any language) into a field on the website; select the date and time from the integrated calendar, and submit the message. This will then be delivered to the mobile phone umber linked with the account at the pre-determined time. No specific guidance is given to these participants regarding their messages. They are able to text anything they like to themselves. The participants are left alone to type this, to allow privacy of message content from the recruiter. Previous research has shown approximately 5% of messages to be "anti-messages" - that is, not related to safe alcohol practices, or even supporting higher alcohol consumption. The researchers consider this to be an acceptable trade-off for allowing free reign, personalised safe use of alcohol related messages in the remaining 95%.

Intervention code [1] 301448 0
Lifestyle
Intervention code [2] 301482 0
Behaviour
Intervention code [3] 301483 0
Prevention
Comparator / control treatment
Control group is arm one. These are patients with alcohol related injuries who will not receive the text message BI but will undertake the AUDIT and (B-YAARCQ) assessments at the same timepoints as arm 2 and arm3 participants.
Control group
Active

Outcomes
Primary outcome [1] 306176 0
Change in Alcohol Use Disorders Identification Test (AUDIT) alcohol screening test from initial assessment (at enrollment) to three month assessment following BI.
Timepoint [1] 306176 0
Assessed at enrollment (baseline), 6 weeks and 3 months following comencement of BI.
Primary outcome [2] 306177 0
Change in the validated brief version of the Young Adults Alcohol Related Consequences Questionnaire (B-YAARCQ) from baseline (at enrollment) to three months following BI.
Timepoint [2] 306177 0
Baseline taken at time of enrollment in study, will first timepoint at 6 weeks and second at 3 months following commencement of delivery of the BI.
Secondary outcome [1] 347767 0
Analysis of the acceptability of the intervention to our population, as measured by recruitment and dropout rates
Timepoint [1] 347767 0
Three months following enrollment

Eligibility
Key inclusion criteria
Participants must be aged 16 years and over, be treated at and/or admitted to the Middlemore Plastic Surgery service with both a personal injury and a history of alcohol consumption in the previous 6 hours, and own a mobile phone
There will be no limit to the number of participants as the interest in and up-take of the service is one of the discovery aims of the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They are under 16 years (children)
They do not own a mobile phone

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)
Centralized randomisation by computer is automatic on enrollment via the customised website.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative outcome measure is change in scores / values from baseline to post-BI. Paired t-testing, one-way ANOVA and repeated measures ANOVA are likely to be used for analysis, depending on the number of measures and variables obtained.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
20/02/2017
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
60
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 10533 0
New Zealand
State/province [1] 10533 0
Auckland

Funding & Sponsors
Funding source category [1] 299693 0
University
Name [1] 299693 0
University of Auckland
Country [1] 299693 0
New Zealand
Primary sponsor type
Individual
Name
Michelle Locke
Address
C/o South Auckland Clinical Campus
Middlemore hospital
Hospital Rd
Otahuhu
Auckland
Country
New Zealand
Secondary sponsor category [1] 299035 0
None
Name [1] 299035 0
Address [1] 299035 0
Country [1] 299035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300596 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 300596 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 300596 0
New Zealand
Date submitted for ethics approval [1] 300596 0
23/05/2016
Approval date [1] 300596 0
10/08/2016
Ethics approval number [1] 300596 0
Ethics ref: 16/CEN/75

Summary
Brief summary
This research utilizes an established website as well as the validated Alcohol Use Disorders Identification Test (AUDIT) alcohol screening test as well as the brief version of the Young Adults Alcohol Related Consequences Questionnaire (B-YAARCQ) to assess and reduce alcohol-related harm. Patients admitted under plastic surgery with personal injury and a history of alcohol intake will be approached for enrolment. They will be directed to the SpillIt website to complete the AUDIT and B-YAARCQ online and consent to take part in the study. From there, they will be randomised to either no text message intervention (control arm), access pre-written (passive arm) or to self-design (active arm) alcohol intervention text messages. If they are randomised to an intervention arm, the messages will be timed to be delivered to their phone when they were most likely to be consuming alcohol, with the aim of encouraging contemplation of their drinking and staying safe. Patients will be followed up at six weeks, then three months and longer if feasible. AUDIT and B-YAARCQ will be re-administered in person or the shortened version (AUDIT-C) may be administered via text messaging. Participant feedback will also be solicited. This research doesn’t demonise alcohol but instead encourages consideration of the unwanted consequences which may result from risky drinking.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2760 2760 0 0
/AnzctrAttachments/375276-HDEC letter full approval Spillit research 10 Aug 2016.pdf (Ethics approval)
Attachments [2] 2775 2775 0 0
/AnzctrAttachments/375276-My Message Schedule.docx (Other)

Contacts
Principal investigator
Name 84162 0
Dr Michelle Locke
Address 84162 0
South Auckland Clinical Campus
2nd Floor, Esme Green building
Middlemore hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 84162 0
New Zealand
Phone 84162 0
+6492760000
Fax 84162 0
+6492760004
Email 84162 0
Michelle.Locke@middlemore.co.nz
Contact person for public queries
Name 84163 0
Dr Michelle Locke
Address 84163 0
South Auckland Clinical Campus
2nd Floor, Esme Green building
Middlemore hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 84163 0
New Zealand
Phone 84163 0
+6492760000
Fax 84163 0
+6492760004
Email 84163 0
Michelle.Locke@middlemore.co.nz
Contact person for scientific queries
Name 84164 0
Dr Michelle Locke
Address 84164 0
South Auckland Clinical Campus
2nd Floor, Esme Green building
Middlemore hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 84164 0
New Zealand
Phone 84164 0
+6492760000
Fax 84164 0
+6492760004
Email 84164 0
Michelle.Locke@middlemore.co.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
No additional documents have been identified.