Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000358640
Ethics application status
Approved
Date submitted
26/03/2014
Date registered
4/04/2014
Date last updated
4/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial 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
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? Are personally designed and scheduled messages more effective in reducing harms than are predesigned & scheduled safe drinking messages?
Secondary ID [1] 284252 0
NIL
Universal Trial Number (UTN)
Nil
Trial acronym
SPILLIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unintended harms due to alcohol intoxication 291367 0
Condition category
Condition code
Injuries and Accidents 291733 291733 0 0
Other injuries and accidents
Public Health 291883 291883 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to 3 month access to a web site which (a) allows them to generate text for their own messages or (b) sends pre-set and pre-timed safe drinking messages. In group (a), 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 web site provides no information on alcohol related harms. It provides no suggested messages or message topics to Group A.

Group (b) will have 3 months access to the web site messaging. Their messages will be pre-set and relate to keeping safe while drinking. (see comparator section)
Intervention code [1] 288958 0
Prevention
Intervention code [2] 289084 0
Behaviour
Comparator / control treatment
For Group B, 20 messages are sent over 13 weeks, primarily on Saturday or Friday and occasionally on Thursday. A participant will receive 2 messages / week on most weeks
Most of the messages are delivered between 8.30 pm and 11.30 pm, as indicated from the feasibility studies. Examples of these messages include:Time to grab some food; I could have a coffee now; Time to call a taxi?;Ease up on the drink
Control group
Active

Outcomes
Primary outcome [1] 291778 0
Reduction in alcohol related harms using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)
Timepoint [1] 291778 0
3 months
Secondary outcome [1] 307514 0
Reduction in alcohol related harms using the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) at 6 months
Timepoint [1] 307514 0
Six months

Eligibility
Key inclusion criteria
Of legal alcohol purchase age
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under legal alcohol purchase age

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)
participants register on a web site (www.spillitnz.co.nz) and are randomised by the web site software to either of the two treatments. Randomisation is based on a pre-set randomisation table.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized in 1:1 rate (block size of 4) to each of the two groups using Fishers Method of Blocked Randomisation programmed into the intervention web site . The pattern consists of groups of 4 with 3 groups completing a pattern for 12 participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
For each treatment group, paired t tests will be used to assess the treatment effect between baseline and 13 weeks and at 6 months using a repeated measures design. Change in consequence scores from baseline to 13 weeks using t tests will assess the effect of the intervention. Change from 13 weeks to 6 months using t tests will assess the longevity of the treatment effect. The feasibility study intervention group, which created self-designed safe drinking messages, reported a reduction in harms of 23% over three months with dropout rate of 17.6% compared with a harm reduction of 3% in the control group (Renner et al, under review). Based on these data, a sample size of 45 participants per group (total 90) is required to provide 90% power at p=0.05 to detect an absolute difference between the two groups of 20%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5889 0
New Zealand
State/province [1] 5889 0

Funding & Sponsors
Funding source category [1] 288878 0
Self funded/Unfunded
Name [1] 288878 0
Country [1] 288878 0
New Zealand
Primary sponsor type
Individual
Name
Karen Renner
Address
General Practice and Primary Health Care
 University of Auckland
Tamaki Campus
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287571 0
Commercial sector/Industry
Name [1] 287571 0
Starsoft Ltd
Address [1] 287571 0
PO Box 300, 789
Albany
Auckland
New Zealand
0340
Country [1] 287571 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290706 0
Health & Disability Ethics Committees
Ethics committee address [1] 290706 0
Ministry of Health
C/- Medsafe
Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington, 6011
Ethics committee country [1] 290706 0
New Zealand
Date submitted for ethics approval [1] 290706 0
04/11/2013
Approval date [1] 290706 0
16/12/2013
Ethics approval number [1] 290706 0
CEN/11/03/101/AM04

Summary
Brief summary
Feasibility studies on the SPILLIT safe drinking intervention have shown that participants are willing to create their own personal safe drinking messages and schedule when these messages should be sent to their mobile phone.

A full RCT is now required to assess the treatment effect of personalised safe drinking messages. This will be accomplished by comparing the SPILLIT intervention design (Treatment A) with a safe drinking intervention which provides pre-designed and scheduled safe drinking messages (Treatment B) to the participants. These pre-designed messages will be sourced from the HPA (ALAC) safe drinking messages (used with permission) and from the anonymous messages generated during the feasibility studies.

I wish to note a change to my protocol to implement this RCT.
Trial website
www.spillitnz.co.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46894 0
Mrs Karen Renner
Address 46894 0
General Practice and Primary Health Care
 University of Auckland

Tamaki Campus
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
Country 46894 0
New Zealand
Phone 46894 0
+(64) 9 923 9170
Fax 46894 0
Email 46894 0
[email protected]
Contact person for public queries
Name 46895 0
Mrs Karen Renner
Address 46895 0
General Practice and Primary Health Care
 University of Auckland

Tamaki Campus
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
New Zealand
Country 46895 0
New Zealand
Phone 46895 0
+(64) 9 923 9170
Fax 46895 0
Email 46895 0
[email protected]
Contact person for scientific queries
Name 46896 0
Mrs Karen Renner
Address 46896 0
General Practice and Primary Health Care
 University of Auckland

Tamaki Campus
261 Morrin Rd,
Tamaki Campus,
Glen Innes, Auckland 1072
New Zealand
Country 46896 0
New Zealand
Phone 46896 0
+(64) 9 923 9170
Fax 46896 0
Email 46896 0
[email protected]

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.