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Trial registered on ANZCTR


Registration number
ACTRN12613000833763
Ethics application status
Approved
Date submitted
17/07/2013
Date registered
30/07/2013
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effect of an interactive decision-aid smartphone smoking cessation application (app) on quit rates: a double-blind randomized control trial
Scientific title
In adult smokers, does an interactive smartphone smoking cessation application, compared to standard information, increase the quit rates?
Secondary ID [1] 282849 0
Nil known
Universal Trial Number (UTN)
U1111-1145-7294
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 289657 0
Condition category
Condition code
Mental Health 289977 289977 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention app includes compulsory information (participants cannot move to the next step before confirming if they have read the provided information and they will be asked if they read all the information, read some of the information, haven’t read anything) about quitting methods and optional information about smoking consequences, multiple compulsory advanced notifications at different stages of the quitting process e.g. at the selected quitting date and daily motivational notifications. In addition, the app will motivate participants to write quitting diaries (e.g. craving triggers). After reviewing the interventions user will be asked if they are willing to quit in and what of the provided options they are willing to use, and then follow how they act on their decision at 4 time-points (10 days, 1 month, 3 months, and 6 months). The participants in both groups will be advised to complete reading the provided information in the first 3 days and setup a quit date within the next 7 days. Participants in the intervention group will be advised to use the app regularly after quitting benefit from the self-help functions. The app will be available for the participants in the intervention group for 6 months, after this period the app will automatically stop the data collection and participants can use it as long as they want. The app will monitor the daily usage data including, number of times the participant open the app, and record the number of times the participants looked at or used any function.
Intervention code [1] 287541 0
Behaviour
Comparator / control treatment
Standard smoking cessation information (including information about smoking consequences, quitting options, and benefit of quitting) will be provided via smartphone app and then follow them up at 4 time-points (10 days, 1 month, 3 months, and 6 months). The participants will be advised to complete reading the provided information in the first 3 days and setup a quit date within the next 7 days. The app will be available for participants in the control group for 6 months, after this period the app will automatically stop the data collection and participants can use it as long as they want. In addition, after the end of data collection period participants in the control group will have access to the intervention app. The app will monitor the daily usage data including, number of times the participant open the app, and record the number of times the participants looked at or used any function.
Control group
Active

Outcomes
Primary outcome [1] 290025 0
Self-reported abstinence rate (Not even a single puff after quitting).
Timepoint [1] 290025 0
4 time-points (10 days, 1 month, 3 months, and 6 months)
Secondary outcome [1] 303800 0
Making informed choice on our multidimensional measure of Informed Choice for smoking (MMICS). At the first follow up (10 days) after collecting the quitting and abstinence data, all participants in both groups will be asked to fill the MMICS questionnaire. The MMICS assess if the participant had made an informed choice of quitting or not.
Timepoint [1] 303800 0
1 time-point (10 days )

Eligibility
Key inclusion criteria
Daily smokers, age 18 and above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Occasional smokers. Age less than 18.

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)
All participants will download the study app. The app will include baseline questionnaire and the intervention & the control apps. After completing the baseline questionnaire, eligible participants will be automatically randomized to either the intervention or control app.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The app will automatically randomize participants to one of the two groups while keeping the two groups balanced based on equal distribution of age country, and gender between the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcome analyses will be conducted on an intention-to-treat basis (with all non-respondents classified as continuing smokers). Logistic regression modelling will be used to assess the effectiveness of the intervention before and after adjustment for the baseline characteristics of the participants.

Sample Size: Based on (4.9%) weighted event rates of 17 trials using standard self-help materials in control group and (13.1%) average abstinence rate in web- and computer-based intervention trials, and assuming at least similar effect for smartphone the study will require 230 participants in each group, at confidence level of 95%, power of 80%, and 20% compliance adjustment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2014
Actual
5/05/2014
Date of last participant enrolment
Anticipated
Actual
1/09/2014
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
684
Accrual to date
Final
684
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5222 0
United States of America
State/province [1] 5222 0
all
Country [2] 5223 0
Singapore
State/province [2] 5223 0
all
Country [3] 5224 0
United Kingdom
State/province [3] 5224 0
all

Funding & Sponsors
Funding source category [1] 287627 0
Self funded/Unfunded
Name [1] 287627 0
Country [1] 287627 0
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
City Rd Darlington NSW 2008
Country
Australia
Secondary sponsor category [1] 286371 0
None
Name [1] 286371 0
Address [1] 286371 0
Country [1] 286371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289598 0
Sydney University Human Research Ethics Committee
Ethics committee address [1] 289598 0
Human Ethics
Margaret Telfer K07
University of Sydney NSW 2006
Ethics committee country [1] 289598 0
Australia
Date submitted for ethics approval [1] 289598 0
Approval date [1] 289598 0
16/07/2013
Ethics approval number [1] 289598 0
2013/513

Summary
Brief summary
In 2012, we conducted a review of free smoking cessation apps in the Apple store and Android market and found that all 130 apps lacked the informational content about smoking which is necessary to help quit. For instance, none of the identified apps provided information about evidence-based treatment (Not published). In phase 1 of this study, we found that of 394 participants, 43% have used smoking cessation apps before, and of them 55% have made a quit attempt using an app. Given that most of the available apps are not of a high quality, our aim is to develop an evidence-based decision aid smartphone app, to help smoker decide on the best available quitting method suitable for them, and follow up their quitting process. The intervention and control apps will be compared in terms of helping participants making quitting attempts and abstinence rate at 4 time-points (10 days, 1 month, 3 months, and 6 months).
Trial website
Trial related presentations / publications
1- BinDhim NF, McGeechan K, Trevena L. Assessing the effect of an interactive decision-aid smartphone smoking cessation application (app) on quit rates: a double-blind automated randomised control trial protocol. BMJ open. 2014 Jul 1;4(7):e005371.

2- BinDhim NF, McGeechan K, Trevena L Smartphone Smoking Cessation Application (SSC App) trial: a multicountry double-blind automated randomised controlled trial of a smoking cessation decision-aid ‘app’ BMJ Open 2018;8:e017105. doi: 10.1136/bmjopen-2017-017105
Public notes

Contacts
Principal investigator
Name 41510 0
Mr Nasser BinDhim
Address 41510 0
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
University of Sydney NSW 2006
Country 41510 0
Australia
Phone 41510 0
+61290367699
Fax 41510 0
Email 41510 0
[email protected]
Contact person for public queries
Name 41511 0
Nasser BinDhim
Address 41511 0
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
University of Sydney NSW 2006
Country 41511 0
Australia
Phone 41511 0
+61290367699
Fax 41511 0
Email 41511 0
[email protected]
Contact person for scientific queries
Name 41512 0
Nasser BinDhim
Address 41512 0
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
University of Sydney NSW 2006
Country 41512 0
Australia
Phone 41512 0
+61290367699
Fax 41512 0
Email 41512 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSmartphone Smoking Cessation Application (SSC App) trial: A multicountry double-blind automated randomised controlled trial of a smoking cessation decision-aid 'app'.2018https://dx.doi.org/10.1136/bmjopen-2017-017105
N.B. These documents automatically identified may not have been verified by the study sponsor.