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Trial registered on ANZCTR


Registration number
ACTRN12617000491369
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
5/04/2017
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Quittr: A game that wants smokers to Quit
Scientific title
Quittr: A smoking cessation serious game. Determining if game features influence smoker engagement and retention during a Quit attempt.
Secondary ID [1] 291578 0
Nil known
Universal Trial Number (UTN)
U1111-1194-8865
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
smoking 302685 0
cardiovascular disease 302686 0
cancer 302687 0
Condition category
Condition code
Public Health 302198 302198 0 0
Health promotion/education
Cardiovascular 302199 302199 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 302200 302200 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Quittr is an innovative smartphone app designed to support smokers through a quit attempt. It provides useful health and financial statistics, educational/behavioural support content, an achievement system, and novel game features that are designed to entice the smoker remain engaged with the app for longer, thereby improving their likelihood of success.

Participants can use the app at their discretion, but are prompted to check in regularly through daily notifications.

To determine whether these game features work as intended, we are enrolling participants at random into one of two groups. The first group has the full features of the Quittr app enabled, while the second group has the game features disabled. This will allow us to detect differences in the outcomes reported for each group.

We will also monitor usage analytics, to determine how engaged the smoker is with the various features of the apps over time.

The intervention group will have access to the full features of Quittr, including the "Tappy Town" incentivisation game and QuitCoin rewards. They will be granted QuitCoins in return for positive behaviours that are likely to improve their chances of quitting smoking (i.e. not smoking, consuming educational content, checking in regularly). The QuitCoins can be redeemed in the Tappy Town incentivisation game. This is a city builder/clicker style game that allows the player to incrementally grow a city by placing a variety of buildings/improvements into the game map. As the city grows so does its income potential, allowing the player to afford gradually more grand buildings and improvements. Some of the best buildings/improvements available in the game can only be purchased by redeeming QuitCoins. The control group will not have access to the Tappy Town game or the associated QuitCoins (at least until after their 28-day trial expires), but the app will otherwise function identically.

The trial will be in effect over a 28-day period from participant enrolment, with enrolment open between 1/06/2017 and 1/11/2017. After the participant reaches 28-days they will be automatically switched back to the fully featured version of the game, and will retain their access to the app.
Intervention code [1] 297640 0
Behaviour
Comparator / control treatment
Participants in the control group will have access to the Quittr app which includes all the progress statistics, educational content, achievements system, and a cravings distraction mini-game. However, they will not have access to the "Tappy Town" incentivisation game and will not be rewarded with QuitCoins for successfully engaging with key systems in the app.

After the 28-day trial period ends, the control group will revert to "normal" fully featured status, gaining access to the games features.
Control group
Active

Outcomes
Primary outcome [1] 301614 0
smoking activity - whenever the smoker opens the app for the first time in a given day, they are prompted to indicate how many cigarettes they have smoked. If they have gone multiple days without logging in, they are prompted to enter their cigarettes for each day missed.
Timepoint [1] 301614 0
daily over a 28-day period
Primary outcome [2] 301615 0
retention of users - is the smoker checking in on a daily basis, measured using usage analytics logs
Timepoint [2] 301615 0
daily over a 28-day period
Secondary outcome [1] 333301 0
engagement of users (composite) - measured as "seconds per page" using usage analytics automatically recorded during use
Timepoint [1] 333301 0
daily over a 28-day period
Secondary outcome [2] 333431 0
truthfulness in self-reported smoking statistics. Where the participant indicates they have successfully quit smoking at the end of the 28-day period, we will seek to verify this finding by, if the participant indicates they are willing, sending them a self-administered cotinine urine analysis test and asking them to photograph the result strip and email it back to the CI.
Timepoint [2] 333431 0
at 28-days

Eligibility
Key inclusion criteria
must be a current smoker who is interested in starting a Quit attempt
must have a compatible mobile device and an internet connection
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil. Anyone who meets the inclusion criteria shall be eligible to participate. There are no foreseeable risks beyond usual care.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation performed by a computer
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
After the user has completed the 28-day study period they will revert to having access to the fully featured version of Quittr.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We anticipate a ~10% 28-day abstinence success rate for those using the app alone, and a ~20% success rate for those using the app with the game features enabled. At a minimum we will aim to recruit 219 patients per group, which will allow us to detect a difference of 0.05 at 80% power.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 296065 0
Charities/Societies/Foundations
Name [1] 296065 0
Vanguard Grants (Heart Foundation of Australia)
Address [1] 296065 0
Level 1/89 Brisbane Street
Hobart TAS 7000
Country [1] 296065 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
1 Churchill Ave
Sandy Bay TAS 7001
Country
Australia
Secondary sponsor category [1] 294958 0
None
Name [1] 294958 0
Address [1] 294958 0
Country [1] 294958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297322 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 297322 0
301 Sandy Bay Road, Sandy Bay 7005
Ethics committee country [1] 297322 0
Australia
Date submitted for ethics approval [1] 297322 0
11/04/2017
Approval date [1] 297322 0
19/06/2017
Ethics approval number [1] 297322 0

Summary
Brief summary
This study will investigate the effectiveness of Quittr, a smoking cessation app.

Who is it for?
You may be eligible to join this study if you are a current smoker interested in starting a quit attempt.

Study details
Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have access to full features Quittr, which include health and financial statistics, educational/behavioural support content, an achievement system, and novel game features. Participants in the other group will have access to the same features except the game. After 28-days the study will end, but participants will continue to have access to the full featured version of the app indefinitely.

Participants will be prompted to indicate how many cigarettes they smoke each day, and usage data will be automatically recorded to a web service. Smoking activity, engagement and retention of users will be determined after the 28 day trial window closes.

Participants who indicate they have successfully quit smoking at the end of the trial will optionally be able to demonstrate this using a self-administered cotinine urine analysis test strip. Volunteers will be posted an simple test kit, asked to photograph the result strip, and return the photograph by email. In return, the volunteer will be granted a $40 gift card as remuneration.
Trial website
Trial related presentations / publications
Bindoff I, de Salas K, Peterson G, Ling T, Lewis I, Wells L, Gee P, Ferguson SG
Quittr: The Design of a Video Game to Support Smoking Cessation
JMIR Serious Games 2016;4(2):e19
DOI: 10.2196/games.6258
PMID: 27908844
PMCID: 5159615
Public notes

Contacts
Principal investigator
Name 73702 0
Dr Ivan Bindoff
Address 73702 0
Pharmacy, Bag 26
University of Tasmania
1 Churchill Ave
Sandy Bay TAS 7001
Country 73702 0
Australia
Phone 73702 0
+61362268537
Fax 73702 0
Email 73702 0
Ivan.Bindoff@utas.edu.au
Contact person for public queries
Name 73703 0
Dr Ivan Bindoff
Address 73703 0
Pharmacy, Bag 26
University of Tasmania
1 Churchill Ave
Sandy Bay TAS 7001
Country 73703 0
Australia
Phone 73703 0
+61362268537
Fax 73703 0
Email 73703 0
Ivan.Bindoff@utas.edu.au
Contact person for scientific queries
Name 73704 0
Dr Ivan Bindoff
Address 73704 0
Pharmacy, Bag 26
University of Tasmania
1 Churchill Ave
Sandy Bay TAS 7001
Country 73704 0
Australia
Phone 73704 0
+61362268537
Fax 73704 0
Email 73704 0
Ivan.Bindoff@utas.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary