Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000159156
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
4/02/2019
Date last updated
3/05/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of electronic resources to help smokers quit
Scientific title
Randomised controlled trial into the acceptability and effect of My Quit Buddy smartphone app on the self-reported quit rate in smokers
Secondary ID [1] 297241 0
none
Universal Trial Number (UTN)
U1111-1227-6588
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nicotine addiction 311309 0
Condition category
Condition code
Mental Health 309939 309939 0 0
Addiction
Public Health 309940 309940 0 0
Health promotion/education
Respiratory 309941 309941 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The publicly available smoking cessation smart-phone app (My Quit Buddy) will be downloaded to the participant's own mobile phone and used ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). My Quit Buddy app usage will be determined by patient questionnaire for three months following randomisation. My QuitBuddy is an app personalised to help people quit smoking, using educational and motivational tools http://www.quitnow.gov.au/internet/quitnow/publishing.nsf/Content/quit-buddy
Intervention code [1] 313492 0
Treatment: Other
Comparator / control treatment
Participants will be directed to the Queensland Health smoking cessation resources web page at https://quithq.initiatives.qld.gov.au/ to be used ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). Web page usage will be determined by participant questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 318859 0
questionnaire of self-reported quit rate using Russell standard
Timepoint [1] 318859 0
3 months post randomization
Secondary outcome [1] 366278 0
uptake and acceptability of smartphone app (uMARS rating scale).
Timepoint [1] 366278 0
at 6 and 12 weeks post randomisation
Secondary outcome [2] 366279 0
self-reported quit rate (participant questionnaire designed specifically for this study)
Timepoint [2] 366279 0
6 weeks post randomisation
Secondary outcome [3] 366342 0
number of quit attempts (participant questionnaire designed specifically for this study)
Timepoint [3] 366342 0
at 6 and 12 weeks post randomisation
Secondary outcome [4] 366343 0
change in motivation score (participant questionnaire designed specifically for this study)
Timepoint [4] 366343 0
at 6 and 12 weeks post randomisation

Eligibility
Key inclusion criteria
Adult smokers (regular daily or non-daily use) able to give informed consent who own a smartphone capable of using the app and have access to a computer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers who do not own a smartphone and/or do not have access to a computer. Smokers who are current users of a smoking cessation smart phone app.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done centrally using computer generated random numbers stratified by hospital site and grouped in blocks of 6
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed Envelope Ltd. 2017. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 7 Jan 2019]
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/02/2019
Actual
4/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301799 0
Government body
Name [1] 301799 0
Queensland Policy and Advisory Committee for new Technology (QPACT)
Country [1] 301799 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road
Chermside
QLD 4032
Country
Australia
Secondary sponsor category [1] 301542 0
None
Name [1] 301542 0
Address [1] 301542 0
Country [1] 301542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302508 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 302508 0
Building 14
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Ethics committee country [1] 302508 0
Australia
Date submitted for ethics approval [1] 302508 0
29/01/2019
Approval date [1] 302508 0
06/02/2019
Ethics approval number [1] 302508 0
Project ID 50373

Summary
Brief summary
Smartphones are increasingly commonplace in the general population. Patient-facing mobile applications (“apps”) are software programs installed on smartphones that offer an opportunity to help modify behaviour of the smartphone user at low cost and with little or no clinician input. Multiple smoking cessation apps exist but very few have been independently evaluated, particularly in a hard-to-treat, hospital setting. The most downloaded smoking cessation app in Australia is My Quit Buddy, developed and marketed for the Department of Health. Preliminary data shows encouraging effects on smoking cessation in a self-selected and self-reported younger user group. Smokers seen in hospital settings are older, perhaps less sophisticated users of information technology with probably more ‘hard core’ nicotine addiction coupled with end-organ disease. The acceptability and potential effects of smoking cessation apps in this population are important to assess.
Aims
We propose a pilot randomized controlled study to help answer these questions and determine the sample size required for a definitive study. The smoking cessation app and standard care (online, generic smoking cessation information provided by Queensland Health) will be delivered as an adjunct to normal standards of care (i.e. as per RACGP guidelines). Both groups will have full access to all standard therapies for smoking cessation including pharmacotherapy, counselling. This study will estimate the incremental effect of My Quit Buddy app on smoking cessation rates at 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90454 0
Dr Henry Marshall
Address 90454 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 90454 0
Australia
Phone 90454 0
+61 7 31394000
Fax 90454 0
Email 90454 0
[email protected]
Contact person for public queries
Name 90455 0
Ms Linda passmore
Address 90455 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 90455 0
Australia
Phone 90455 0
+61 07 31396632
Fax 90455 0
Email 90455 0
[email protected]
Contact person for scientific queries
Name 90456 0
Dr Henry Marshall
Address 90456 0
Department of Thoracic Medicine
The Prince Charles Hospital
Rode Road
Chermside
QLD 4032
Country 90456 0
Australia
Phone 90456 0
+61 7 31394000
Fax 90456 0
Email 90456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Complete de-identified patient data set
When will data be available (start and end dates)?
With publication
Available to whom?
Teams with requisite expertise and HREC approved protocols
Available for what types of analyses?
any that have received HREC approval
How or where can data be obtained?
electronic transfer


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.