Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000453482
Ethics application status
Approved
Date submitted
4/04/2016
Date registered
7/04/2016
Date last updated
21/08/2019
Date data sharing statement initially provided
21/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart phone based Problem Gambling Evaluation and Technology Testing Initiative (SPGETTI) Phase II
Scientific title
Smart phone based Problem Gambling Evaluation and Technology Testing Initiative (SPGETTI) Phase II
Secondary ID [1] 288921 0
NIL
Universal Trial Number (UTN)
Trial acronym
SPGETTI-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem Gambling 298256 0
Condition category
Condition code
Mental Health 298401 298401 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provide a behavioral intervention program delivered by mobile phone app to problem gamblers to support their relapse prevention. This intervention is in addition to usual/standard care.

The intervention is multi-pronged with a set of standard structured messages that are aimed at strategies for avoiding risk triggers., maintaining wellness, etc. The number and timing of these messages are participant selected to match when they believe that they are most at risk for relapsing and how much support (frequency of messages) they identify they need. the intensity can be between 1 - 5 messages a day.. Once this is selected the participant receives these and does not need to activate the app further unless they wish to adjust the frequency or timing. Two additional strategies within the app program are 1. a GPS locator activated on the participants phone which has coordinates mapped to gambling premises will be used to trigger an intervention that is more intensive and specific to that occasion - i.e. when they appear to be in a gambling venue. These messages are currently being refined. However, they will be specifically shaped to facilitate the recognition of immediate risk of being exposed to cues and triggers that could influence a gambling relapse along with some immediate and actionable strategies to resist and avoid these cues; 2. a rescue icon will also be able to be activated by the participant when they feel that they need additional help. This will be linked to more tailored messages, the problem gambling line contact numbers, and their counselor (if appropriate).
The intervention will be implemented for 1 month in total.
Some monitoring will be undertaken through the app. The app will have location technology activated, This will be used to assess potential exposure (triggers) to gambling venues. Times spent in these locations will be captured to help with contextualizing abstinence and relapses. Self reported abstinence or relapse will be collected at the 1 month end point.
Intervention code [1] 294384 0
Behaviour
Intervention code [2] 294409 0
Treatment: Devices
Comparator / control treatment
There is no comparator / control group now.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297877 0
Continuous abstinence from gambling. this will be measured by self report, and frequency of being in a gambling locaiton (as defined by GPS technology within app).
Timepoint [1] 297877 0
At one month from randomisation
Secondary outcome [1] 322502 0
We will measure the same outputs however the study design has changed and there is no control arm. As such we will measure the number of participants in the study who are continuously abstinent (as measured by no lapses, with a lapse defined as exceedance of the specified parameters of the GPS location venue zones. All lapses will be measured objectively using data collected by the app and by self-report. This change has occurred after the original study began.
Timepoint [1] 322502 0
At one month from randomisation
Secondary outcome [2] 322576 0
The acceptability of the app and its perceived usefulness in preventing relapse and in assisting with the goal of achieving abstinence.. The Unified Theory of Acceptance and Use of Technology framework will be used to measure this outcome. A brief survey that enables assessment to be collected from the participants on 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions
Timepoint [2] 322576 0
at one month from randomisation

Eligibility
Key inclusion criteria
Participants are classified into gambling subtypes based on their G-SAS score captured at baseline. Recruitment is based on self selection and exclusion criteria is aged 17 years or less and /or do not own an android smart phone capable of downloading an app. This change has been initiated after the original study design was implemented.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not owning a smart phone capable of downloading an app.
Significant mental health illness or other long term condition that precludes ability to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No randomisation now being undertaken. Allocation is a single arm and self selected. This change was made after the RCT had commensed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation now being undertaken as such .there is no use of a computer generated randomisation sequence Allocation is single arm and self selected. This change was made after the RCT had commenced.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
All participants are now receiving the intervention app with the GPS technology enabled.
There is no longer a placebo app. All participants will now receive the full app.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The design of the study has changed to a non-RCT after the study started and as such the original power analyses do not apply.

We will continue to initially analyse the data using descriptive statistics with the proportions of abstinence presented as frequency and percentages. We will not be undertaking any analyses using unadjusted relative risk or doing any proportion testing or , relative risk and associated 95% confidence intervals will be determined. No hypothesis testing will be performed.

The primary outcome will be analysed using a logistic regression model with associated odds ratio on the probability of abstinence at the participant level (i.e. yes/no abstinence), controlling for important confounding factors. However, no comparison group will be part of these analyses.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2016
Actual
1/11/2016
Date of last participant enrolment
Anticipated
30/09/2018
Actual
30/09/2018
Date of last data collection
Anticipated
31/10/2018
Actual
31/10/2018
Sample size
Target
250
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7768 0
New Zealand
State/province [1] 7768 0
Auckland

Funding & Sponsors
Funding source category [1] 293270 0
Government body
Name [1] 293270 0
Ministry of Health
Country [1] 293270 0
New Zealand
Primary sponsor type
Individual
Name
Professor Chris Bullen
Address
National Institute for Health Innovation (NIHI),
School of Population Health
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292073 0
None
Name [1] 292073 0
Address [1] 292073 0
Country [1] 292073 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294748 0
NZ health and disability ethics committee
Ethics committee address [1] 294748 0
Ethics committee country [1] 294748 0
New Zealand
Date submitted for ethics approval [1] 294748 0
09/06/2016
Approval date [1] 294748 0
22/06/2016
Ethics approval number [1] 294748 0
16NTA86

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64910 0
Prof Chris Bullen
Address 64910 0
National Institute for Health
University of Auckland
Private Bag 92019,
Auckland 1142.
Country 64910 0
New Zealand
Phone 64910 0
+64 21415267
Fax 64910 0
Email 64910 0
[email protected]
Contact person for public queries
Name 64911 0
Gayl Humphrey
Address 64911 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019,
Auckland 1142.
Country 64911 0
New Zealand
Phone 64911 0
+64 211100901
Fax 64911 0
Email 64911 0
[email protected]
Contact person for scientific queries
Name 64912 0
Chris Bullen
Address 64912 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019,
Auckland 1142.
Country 64912 0
New Zealand
Phone 64912 0
+64 21415267
Fax 64912 0
Email 64912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval was not obtained to enable the sharing of IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4124Clinical study reportHumphrey, G., Newcombe, D., Whittaker, R., Parag, V., Bullen, C (2019) SPGeTTI: a Smartphone-Based Problem Gambling Evaluation And Technology Testing Initiative Final Report National Institute for Health Innovation. Prepared for the Ministry of Health. Auckland, New Zealand: Auckland UniServices Limited. The University of Auckland.https://www.health.govt.nz/publication/spgetti-smartphone-based-problem-gambling-evaluation-and-technology-testing-initiative 



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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