Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001550493
Ethics application status
Approved
Date submitted
7/11/2016
Date registered
10/11/2016
Date last updated
3/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can’t Even Quit - A pilot randomised, controlled trial of of an mHealth intervention to promote smoking abstinence for Aboriginal and Torres Strait Islander people
Scientific title
Can’t Even Quit - A pilot randomised, controlled trial of of an mHealth intervention to promote smoking abstinence for Aboriginal and Torres Strait Islander people
Secondary ID [1] 290478 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use 300851 0
Condition category
Condition code
Public Health 300672 300672 0 0
Health promotion/education
Mental Health 300695 300695 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a smartphone mobile phone application to assist in smoking cessation. The application is accessible via the iTunes or Google Play store to registered trial participants who have been randomised to receive the intervention and will be available for 6 months. The application has a range of features to assist with smoking cessation including SMS motivational messages at a frequency customised by the participant, educational tips on health improvements associated with smoking cessation, access to smoking cessation counselling support via Quitline and a social engagement function where participants are able to challenge other people to quit smoking related actions. Participants are free to use the app as much or as little as they choose. Usage will be assessed through data extracted from the software platform at the end of the study.
Intervention code [1] 296335 0
Behaviour
Intervention code [2] 296346 0
Treatment: Other
Comparator / control treatment
Usual health care will be provided by the participant's usual healthcare provider. This consists of brief intervention smoking cessation advice, recommending smoking cessation therapies such as nicotine replacement therapy and access to counselling support through services such as Quitline.
Control group
Active

Outcomes
Primary outcome [1] 300098 0
Self-reported continuous abstinence as assessed by either face to face or telephone interview and verified by carbon monoxide breath analysis.
This is defined as no more than five cigarettes smoked in the past week at 4 weeks follow-up AND no more than five cigarettes smoked since the start of the abstinence period at 6 months of follow-up. A carbon monoxide metre breath test at 6 months of follow-up of >8 represents recent tobacco smoking.
Timepoint [1] 300098 0
4 weeks and 6 months post randomisation
Secondary outcome [1] 329041 0
Self-reported point prevalence of abstinence as assessed by either face to face or telephone interview and verified by carbon monoxide breath analysis. Point prevalence abstinence is defined as no more than five cigarettes smoked in the past 7 days. A carbon monoxide metre breath test at 6 months of follow-up of >8 represents recent tobacco smoking.
Timepoint [1] 329041 0
4 weeks and 6 months post randomisation
Secondary outcome [2] 329042 0
Self-reported continuous abstinence since the start of the abstinence period as assessed by either face to face or telephone interview and verified by carbon monoxide breath analysis.
This is defined as no more than five cigarettes smoked since the start of the abstinence period (as reported by the participant) and will be assessed at 6 months post randomisation. A carbon monoxide metre breath test at 6 months of follow-up of >8 represents recent tobacco smoking.
Timepoint [2] 329042 0
6 months post randomisation
Secondary outcome [3] 329043 0
Self-reported 28 day abstinence as assessed by either face to face or telephone interview and verified by carbon monoxide breath analysis. This is defined as no more than five cigarettes smoked in the 28 days prior to the 6 month follow-up visit. A carbon monoxide metre breath test at 6 months post randomisation of >8 represents recent tobacco smoking.
Timepoint [3] 329043 0
6 months post randomisation
Secondary outcome [4] 329044 0
Use of adjunctive smoking cessation therapy as assessed by either face to face or telephone interview
Timepoint [4] 329044 0
6 months post randomisation

Eligibility
Key inclusion criteria
Consenting Aboriginal people with access to an Android or iOS phone who are willing to make a quit attempt in the next month
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not able to provide informed consent
No access to an Android or iOS phone
Not willing to make a quit attempt in the next 30 days

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)
Web-based 1:1 centralised allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies the abstinence rate is assumed to be double that of the control arm. 1000 participants would be needed to detect a 5% absolute difference (ie: 10.0% vs 5.0%; relative risk 2.00), assuming a 15% loss to follow-up, 2a=0.05 and 80% probability of detecting a significant difference with p values <0.05 judged as significant. This study will be a pilot RCT in which 200 participants will be recruited to assess feasibility, resource considerations, acceptability and preliminary effectiveness data to inform a future, adequately powered trial.

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
Actual
16/03/2016
Date of last participant enrolment
Anticipated
31/01/2017
Actual
13/01/2017
Date of last data collection
Anticipated
31/07/2017
Actual
31/07/2017
Sample size
Target
200
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294894 0
Government body
Name [1] 294894 0
NSW Department of Health
Country [1] 294894 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health
Address
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country
Australia
Secondary sponsor category [1] 293731 0
None
Name [1] 293731 0
Address [1] 293731 0
Country [1] 293731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296273 0
AHMRC Human Ethics Research Committee
Ethics committee address [1] 296273 0
Level 3, 66 Wentworth Ave, Surry Hills, NSW, 2010
Ethics committee country [1] 296273 0
Australia
Date submitted for ethics approval [1] 296273 0
18/05/2015
Approval date [1] 296273 0
26/07/2015
Ethics approval number [1] 296273 0
TBC

Summary
Brief summary
The trial will test whether a smartphone app, when combined with usual smoking cessation support services, will double smoking abstinence rates at 6 months for Aboriginal people trying to make a quit attempt.

This study will be a pilot randomised controlled trial involving approximately 200 Aboriginal smokers. Data will be collected at baseline, 4 weeks and 6 months by a project officer who is blinded to group allocation. Eligible participants are consenting Aboriginal people (aged over 16 years), with access to an Android or iOS phone and who are willing to make a quit attempt in the next month.
Trial website
http://www.cantevenquit.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70226 0
Prof David Peiris
Address 70226 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 70226 0
Australia
Phone 70226 0
+61 2 8052 4513
Fax 70226 0
Email 70226 0
dpeiris@georgeinstitute.org
Contact person for public queries
Name 70227 0
David Peiris
Address 70227 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 70227 0
Australia
Phone 70227 0
+61 2 8052 4513
Fax 70227 0
Email 70227 0
dpeiris@georgeinstitute.org
Contact person for scientific queries
Name 70228 0
David Peiris
Address 70228 0
The George Institute for Global Health
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050 Australia
Country 70228 0
Australia
Phone 70228 0
+61 2 8052 4513
Fax 70228 0
Email 70228 0
dpeiris@georgeinstitute.org

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

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