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Trial registered on ANZCTR


Registration number
ACTRN12617000514303
Ethics application status
Approved
Date submitted
20/03/2017
Date registered
7/04/2017
Date last updated
7/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Real-time video counselling for smoking cessation in regional and remote areas
Scientific title
A randomised controlled trial of the effectiveness of real-time video counselling on smoking cessation in smokers residing in regional and remote areas
Secondary ID [1] 291479 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 302541 0
Condition category
Condition code
Public Health 302081 302081 0 0
Health promotion/education
Mental Health 302266 302266 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real time video-counselling intervention: Smokers in the video-counselling condition will receive from smoking cessation advisors up to six video sessions via Skype, Face Time or other mode of video communication. An evidence-based schedule that accounts for the greatest probability of relapse and involves most calls being scheduled in the critical first two weeks following a quit attempt will be used. For smokers who nominate a quit date, they will receive the initial video session, followed by video sessions on the quit date and 3-, 7-, 14- and 30-days after the quit date. For those who are not ready to set a quit date, they will receive the initial video session followed by sessions at 2-, 4- and 6- weeks after the initial video session. Each participant will receive a maximum of 6 video sessions and each video session will be approximately 10-15 minutes in duration. The maximum of 6 video sessions allows the participant to complete all video sessions in the ready to quit callback schedule (i.e. initial, on quit date, 3-, 7- 14- and 30 days after quit date). Participants will be offered up to 6 video sessions and the number of video sessions they agree to take will be recorded. During the first video counselling session the smoking cessation advisor will assess the participant’s smoking history, discuss the barriers to smoking cessation, identify potential solutions for overcoming these difficulties, and provide information about strategies that can assist the smoker to quit such as nicotine replacement therapies. For subsequent video counselling sessions, the smoking cessation advisor will: assess smoking status; discuss potential triggers for smoking (e.g., alcohol, stress, tea/coffee) and identify potential strategies for coping with triggers; reinforce the benefits of using effective quitting aids; encourage the participant to set tasks to assist with quitting (e.g., listing goals, disadvantages of smoking); and discuss relapse prevention strategies and strengthening self-efficacy. To examine intervention adherence, the smoking cessation advisors will record the number of calls each participant receives, timing of these calls (i.e. according to the callback schedule), content discussed and the duration of each call.
Intervention code [1] 297545 0
Treatment: Other
Intervention code [2] 297546 0
Lifestyle
Intervention code [3] 297547 0
Behaviour
Comparator / control treatment
Proactive telephone counselling (comparator): Smokers allocated to this condition will receive from smoking cessation advisors up to six proactive telephone counselling calls. The timing of the telephone callback schedule and the content of the calls will be identical to that used for the real-time video counselling sessions. Smokers who are ready to set a quit date will receive six relapse-responsive proactive telephone counselling calls on the initial call, on the quit date and 3-, 7-, 14- and 30-days after the quit date. Those who are not ready to set a quit date, will be offered telephone calls initially and at 2-, 4- and 6- weeks after the initial call..

Written self-help materials (control): Control participants will be mailed written self-help materials (i.e. a quit kit) after completion of their baseline survey. The quit kit used in this study is the same resource that is offered to those who call the NSW Quitline for smoking cessation support. The quit kit will contain information about the benefits of quitting smoking, effective strategies and products that can assist with quitting, and suggestions on how to remain smoke-free.
Control group
Active

Outcomes
Primary outcome [1] 301515 0
Point prevalence abstinence: The primary outcome is 7-day point prevalence abstinence. To achieve 7-day point prevalence abstinence, participants will have to answer no to “Have you smoked at least part of a cigarette in the last 7 days?” and “Have you used any of those other forms of tobacco, for example pipes or cigars, in the last 7 days?”
Timepoint [1] 301515 0
13 months post-baseline (although also measured at 4-, and 7-months post-baseline)
Secondary outcome [1] 332888 0
Prolonged abstinence: Prolonged abstinence will be measured from a 1-month post-recruitment grace period (to give smokers opportunity to quit) to each follow-up and between surveys, resulting in 3-, 6-, 9- and 12-months prolonged abstinence. To achieve prolonged abstinence participants will have to answer no to “Since [date] did you smoke at all, even part of a cigarette?” and “Since [date] have you used any other forms of tobacco, for example, pipes or cigars?” The [date] will relate to the end of the 1-month post-recruitment grace period during the 4-month survey and the preceding follow-up for the 7- and 13-month assessments.
Timepoint [1] 332888 0
13 months post-baseline (although also measured at 4- and 7-months post-baseline)
Secondary outcome [2] 332890 0
Quit attempts: Participants will be asked if they quit for one day or longer since the last survey. The proportion of smokers making a quit attempt will be compared between groups.

Timepoint [2] 332890 0
13-months post-baseline (although also measured at 4- and 7-months post-baseline)
Secondary outcome [3] 333551 0
Cost-effectiveness: The costs of delivering the 1) real-time video counselling; 2) proactive telephone counselling; and 3) written self-help materials will be recorded and will vary. The measures of effectiveness for each intervention will be: 1) 7-day point prevalence abstinence and 2) prolonged abstinence. Costs for each condition will include:
Real-time video counselling condition: Smoking cessation advisor labour, and internet costs
Proactive telephone counselling condition: Smoking cessation advisor labour, and telephone costs
Written self-help materials condition: Cost of materials, including distribution costs (i.e. packaging and postage costs).
Timepoint [3] 333551 0
13-months post-baseline (although also measured at 4- and 7-months post-baseline)
Secondary outcome [4] 333552 0
Mental health: The PHQ-4 is a 4-item measure that contains anxiety and depression scales. The PHQ-4 will be used to evaluate the impact of the smoking cessation support (i.e., video or telephone or written materials) on participants’ anxiety and depression.
Timepoint [4] 333552 0
13-months post-baseline (although also measured at 4- and 7-months post-baseline)

Eligibility
Key inclusion criteria
Eligibility criteria for study participation will be: 1) daily tobacco use; 2) aged 18 years or older; 3) access to a mode of video-communication (e.g. Skype, Face Time); 4) access to the internet; 5) access to a telephone; 6) a current e-mail address; and 7) reside in a regional or remote area of New South Wales, Australia.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: 1) occasional or no tobacco use; 2) aged <18 years; 3) no access to a mode of video-communication (e.g. Skype, Face Time); 4) no access to the internet; 5) no access to a telephone; 6) no current e-mail address; and 7) reside in a major city in New South Wales, Australia or in another Australian state.

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)
Central randomisation by 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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis will be completed using SAS software. Categorical data will be described using proportions and continuous data by means, standard deviations and medians. Logistic regressions will test for a significant difference in 7-day point prevalence abstinence, prolonged abstinence and quit attempts between the conditions. Analyses will be on an intention-to-treat basis. Those lost to follow-up will be considered smokers.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW

Funding & Sponsors
Funding source category [1] 295955 0
Government body
Name [1] 295955 0
Cancer Institute New South Wales
Address [1] 295955 0
Level 9,
8 Central Avenue,
Australian Technology Park,
Eveleigh NSW 2015
Country [1] 295955 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294841 0
None
Name [1] 294841 0
Not applicable
Address [1] 294841 0
Not applicable
Country [1] 294841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297227 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 297227 0
University Drive
Callaghan NSW 2308
Ethics committee country [1] 297227 0
Australia
Date submitted for ethics approval [1] 297227 0
Approval date [1] 297227 0
17/06/2016
Ethics approval number [1] 297227 0
H-2016-0148

Summary
Brief summary
Objective: To examine the effectiveness and cost-effectiveness of real-time video counselling compared to: proactive telephone counselling; and self-help materials (control) in achieving smoking abstinence among smokers living in regional and remote areas.
Design: A three-arm, parallel, randomised controlled trial will be conducted with 1,842 smokers residing in regional and remote areas of NSW. Participants will be randomised into one of three conditions: 1) real-time video counselling delivered by smoking cessation advisors; 2) proactive telephone counselling delivered by smoking cessation advisors; or 3) written self-help materials (control). Online assessments will occur at baseline and 4-months, 7-months and 13-months post-baseline to measure smoking cessation.
Methods: Smokers will be recruited via traditional and online ads and other promotions. The Accessibility and Remoteness Index of Australia (ARIA+) will be used to recruit smokers living in regional and remote areas of NSW. Eligibility criteria are: 1) daily tobacco use; 2) aged 18 years or older; 3) access to a mode of video-communication (e.g. Skype, Face Time); 4) telephone access; 5) internet access; 6) a current e-mail address; and 7) reside in a regional or remote area of NSW. Potential participants will be asked to complete an online screening survey and those who meet eligibility criteria will be automatically redirected to the online baseline survey. At the end of the baseline survey, a random number generator will randomly allocate the participant to one of the three conditions. The hyperlink to online follow-up surveys will be e-mailed to participants, 4-, 7- and 13-months post-baseline.
Real time video-counselling condition: Participants in the video counselling condition will be contacted via video communication (e.g. Skype or Face Time). Smokers in the video counselling condition will receive from a smoking cessation advisor up to six video counselling sessions to assist smokers to quit.
Proactive telephone counselling condition: Smokers allocated to the proactive telephone counselling condition will receive from a smoking cessation advisor up to six telephone counselling sessions to assist smokers to quit.
Control condition: Participants allocated to the control condition will be mailed self-help materials (i.e. a quit kit).
Measures:
Point prevalence abstinence (primary outcome): The primary outcome will be self-reported 7-day point prevalence abstinence and will be measured at 4-, 7- and 13-months post-baseline.
Prolonged abstinence (secondary outcome): Prolonged abstinence will be measured from a 1-month post-recruitment grace period (to give smokers opportunity to quit) to each follow-up and between surveys, resulting in 3-, 6-, 9- and 12-months prolonged abstinence.
Quit attempts (secondary outcome): Participants will be asked if they quit for one day or longer since the last survey.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73394 0
Dr Flora Tzelepis
Address 73394 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 73394 0
Australia
Phone 73394 0
+61249246275
Fax 73394 0
Email 73394 0
Flora.Tzelepis@newcastle.edu.au
Contact person for public queries
Name 73395 0
Dr Flora Tzelepis
Address 73395 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 73395 0
Australia
Phone 73395 0
+61249246275
Fax 73395 0
Email 73395 0
Flora.Tzelepis@newcastle.edu.au
Contact person for scientific queries
Name 73396 0
Dr Flora Tzelepis
Address 73396 0
University of Newcastle & Hunter New England Population Health
Locked bag 10
Wallsend NSW 2287
Country 73396 0
Australia
Phone 73396 0
+61249246275
Fax 73396 0
Email 73396 0
Flora.Tzelepis@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results