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Trial registered on ANZCTR
Registration number
ACTRN12619000534189
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
3/04/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
S-Check App Trial: To determine the feasibility and efficacy of the S-Check App as a self-administered harm reduction and early intervention tool for those who use methamphetamine.
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Scientific title
Feasibility and efficacy of the S-Check App: A harm reduction and early intervention smartphone application for methamphetamine use
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Secondary ID [1]
297829
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
S-Check App Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder
312198
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Condition category
Condition code
Mental Health
310743
310743
0
0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The S-Check App has been developed as a self-administered smartphone based harm reduction and early intervention application for those who use methamphetamine. The S-Check App will be provide the user with information to manage their methamphetamine use and support services available, should they need to seek help. One group will be randomize to have immediate access to the App for 28 days while the one group will be randomize to have delayed access to the App 28 days later. Both groups will be asked to complete a surveys at the start and 28 days to assess whether there has been any behavioral change in their methamphetamine use.
Frequency and use of the features of the App will be at the discretion of the participant for the 28 days that they will have access to the App. The App has several sections, such as physical health, social health and psychological well being. The participant will be able to enter information into these sections and the App will be able to provide advice based on the associated risk of the information supplied. The App also has a diary section, where the participant can write and upload videos, audio and pictures to seek track of their progression. They will be awarded achievement badges upon completion of each section of the App. Internal metrics will capture which sections of the App are used, the frequency and the duration of App use. This information together with the surveys will assist the study team in determining the efficacy and feasibility of the App as a harm reduction and early intervention tool.
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Intervention code [1]
314066
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Behaviour
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Intervention code [2]
314103
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Treatment: Other
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Comparator / control treatment
The delayed group will not have access to the S-Check App for 28 days.
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Control group
Active
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Outcomes
Primary outcome [1]
319592
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To see whether the S-Check App can motivate behavioural change amongst people who use methamphetamine. Participants in both arms will be asked to complete the Readiness to Change, General Help-Seeking and Actual Help Seeking Surveys. Those who have immediate access to the App will complete the surveys at the start of the trial and 28 days following usage of the App. Those who have been randomised to having delayed access will complete the survey at the start of the trial and then again at 28 days before having access. The data from both groups will be reviewed to assess whether the App motivated change in behaviour.
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Timepoint [1]
319592
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28 days
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Secondary outcome [1]
368885
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To assess App usability. Participants will be invited to participate in a telephone interview to provide feedback on the use of the App. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
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Timepoint [1]
368885
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Days 28 and 56.
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Secondary outcome [2]
368886
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To assess App usage. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
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Timepoint [2]
368886
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Days 28 and 56.
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Secondary outcome [3]
368888
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To assess App engagement by treatment naive people. Internal App metrics will also be collected to determine the frequency and use of the features of the App,
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Timepoint [3]
368888
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Days 28 and 56.
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Secondary outcome [4]
368890
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To assess predictors of engagement (by age, gender, sexual orientation, duration and frequency of methamphetamine use, previous or current treatment participation). Questions regarding age, gender, sexual orientation, duration and frequency of methamphetamine use, previous or current treatment participation and frequency of methamphetamine use have been included as part of the trial. The information obtained will assess predictors of engagement.
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Timepoint [4]
368890
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Days 28 and 56.
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Secondary outcome [5]
368892
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To understand participant experiences in using the App and factors affecting engagement and impact. Participants will be invited to participate in a telephone interview to provide feedback on the use of the App. Internal App metrics will also be collected to determine the factors affecting engagement and impact of the App,
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Timepoint [5]
368892
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Days 28 and 56.
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Eligibility
Key inclusion criteria
• Be aged over 18 years old
• Currently residing in Australia
• Report use of methamphetamine at least once within the previous month
• Have access to an individualised smartphone for the duration of the study (56 days)
• Be willing and able to provide informed consent (via the S-Check App)
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Minimum age
18
Years
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Maximum age
No limit
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
There are no exclusion criteria.
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Study design
Purpose of the study
Educational / counselling / training
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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)
Allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Wait controlled. Participants are either randomized to have immediate access to the S-Check App (case group) or wait 28 days before having access to the S-Check App (Control).
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Phase
Not Applicable
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Type of endpoint(s)
Efficacy
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Statistical methods / analysis
510 participants will be recruited in the delayed access group and 510 participants in the immediate access group. Overall, 1020 participants will be recruited altogether. The study is designed to detect a medium effect size (e.g. d=0.5, 20) with a power of 0.8 and alpha set at 0.05. To allow for attrition, 1020 participants will be recruited, with an estimated drop-out rate of 50% at Day 28.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/05/2019
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Actual
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Date of last participant enrolment
Anticipated
1/01/2020
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Actual
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Date of last data collection
Anticipated
30/04/2020
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Actual
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Sample size
Target
1020
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
13526
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment postcode(s) [1]
26146
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2010 - Darlinghurst
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Funding & Sponsors
Funding source category [1]
302351
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Government body
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Name [1]
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NSW Health
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Address [1]
302351
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NSW Ministry of Health
73 Miller St
NORTH SYDNEY NSW 2060
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Country [1]
302351
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Sydney Ltd
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Address
St Vincent's Hospital Sydney
390 Victoria St
DARLINGHURST NSW 2010
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Country
Australia
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Secondary sponsor category [1]
302263
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None
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Name [1]
302263
0
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Address [1]
302263
0
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Country [1]
302263
0
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Other collaborator category [1]
280625
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University
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Name [1]
280625
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University of New South Wales Sydney
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Address [1]
280625
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UNSW Sydney NSW 2052 Australia
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Country [1]
280625
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Australia
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Other collaborator category [2]
280626
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University
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Name [2]
280626
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University of Newcastle
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Address [2]
280626
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University Dr, Callaghan NSW 2308
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Country [2]
280626
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303025
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St Vincent's Hospital Human Research Ethics Committee
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Ethics committee address [1]
303025
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St Vincent's Hospital HREC
390 Victoria St
DARLINGHURST NSW 2010
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Ethics committee country [1]
303025
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Australia
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Date submitted for ethics approval [1]
303025
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30/07/2018
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Approval date [1]
303025
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20/09/2018
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Ethics approval number [1]
303025
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HREC/18/SVH/196
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Summary
Brief summary
The main purpose of this trial is to see whether the S-Check App can motivate behavioural change in those who use methamphetamine. The S-Check App has been developed as a harm reduction and early intervention tool It provides information on methamphetamine use and provides information on support services. One group will be randomised to have immediate access to the App for 28 days. The other group will have have access to the App after 28 days (delayed access). Both group at baseline (Day 0) will be asked to complete the Readiness to Change, General Help-Seeking and Actual Help-Seeking questionnaires. Those given immediate access to the App will repeat the survey at 28 days. Those given delayed access will repeat the survey before access is given. Both groups will also be asked to participate in a telephone interview to capture their experience using the App. App usage metrics will also be collected. The information collected will assist to further develop the App as a self-administered tool for those who use methamphetamine but do not wish seek traditional modes of treatment.
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Trial website
www.scheckapp.org.au
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Trial related presentations / publications
Nil
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Public notes
For further information about the S-Check App, please contact : scheckapptrial@nccred.org.au
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Contacts
Principal investigator
Name
92210
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A/Prof Nadine Ezard
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Address
92210
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Drug and Alcohol Service
St Vincent's Hospital Sydney
390 Victoria St
DARLINGHURST NSW 2010
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Country
92210
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Australia
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Phone
92210
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+61 2 8382 1012
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Fax
92210
0
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Email
92210
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Nadine.Ezard@svha.org.au
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Contact person for public queries
Name
92211
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Mr Quoc Nguyen
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Address
92211
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National Centre for Clinical Research on Emerging Drugs (NCCRED)
National Centre for Drug and Alcohol Research (NDARC)
University of NSW Sydney
22-32 King St, RANDWICK NSW 2031
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Country
92211
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Australia
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Phone
92211
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+61 2 9385 0151
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Fax
92211
0
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Email
92211
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q.a.nguyen@unsw.edu.au
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Contact person for scientific queries
Name
92212
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Mr Quoc Nguyen
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Address
92212
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National Centre for Clinical Research on Emerging Drugs (NCCRED)
National Centre for Drug and Alcohol Research (NDARC)
University of NSW Sydney
22-32 King St, RANDWICK NSW 2031
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Country
92212
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Australia
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Phone
92212
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+61 2 9385 0151
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Fax
92212
0
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Email
92212
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q.a.nguyen@unsw.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All participants will be anonymous. Only group data will be used in any analysis or publications.
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What supporting documents are/will be available?
Informed consent form
Ethical approval
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How or where can supporting documents be obtained?
Type [1]
1767
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Informed consent form
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Citation [1]
1767
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Link [1]
1767
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Email [1]
1767
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Other [1]
1767
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The participant information sheet and consent form will also be available: www.scheckapp.org.au
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Attachment [1]
1767
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/Steps11and12/377288-(Uploaded-01-04-2019-10-40-22)-Study-related document.pdf
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Type [2]
1769
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Ethical approval
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Citation [2]
1769
0
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Link [2]
1769
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Email [2]
1769
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Other [2]
1769
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All approval letters as of the 19th March 2019
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Attachment [2]
1769
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/Steps11and12/377288-(Uploaded-01-04-2019-10-47-18)-Study-related document.pdf
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Summary results
No Results
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