None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed