Howard Bridget C, Donnelly Sorcha, McRobbie Hayden, Barker Daniel, Petrie Dennis, Stockings Emily, Brown Jamie, Naughton Felix, Whittaker Robyn, Shakeshaft Anthony, Patel Kieran, Anderson Jack, Thomas Dennis, West Robert, Courtney Ryan J
National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.
Hunter Medical Research Institute, New Lambton Heights, Australia.
Addiction. 2025 Jan;120(1):174-183. doi: 10.1111/add.16662. Epub 2024 Sep 16.
Signficant inequalities in tobacco smoking exist, with higher smoking rates among people from low-socio-economic status (low-SES) populations. Tailored technology-based programs for low-SES smoking populations have the potential for high reach, but require effectiveness data from large-scale trials. This trial among Australians who smoke from a low-SES background will determine the effectiveness and cost-effectiveness of tailored text-message (TTM) support compared with standard Quitline (SQL) telephone support service.
DESIGN, SETTING AND PARTICIPANTS: This is a two-arm, parallel group, randomized, non-inferiority trial with allocation concealment and blinded outcome assessment in an Australian population within the greater Sydney region in New South Wales. Participants are adults who smoke daily (n = 1246), are interested in quitting and currently receiving a government pension or allowance, and will be recruited via advertisements.
Participants will be randomized (1:1 ratio) to receive either 12 months of TTM quit support or enrolment in SQL telephone support.
Assessments will be completed at baseline (telephone interview), within 1 month (check-in call), at 3 months (on-line questionnaire) and 12 months (telephone interview) post-randomization. The primary outcome will be 6-month continuous abstinence verified by carbon monoxide breath test at 12-month follow-up. The study will test whether TTM is non-inferior to SQL by a non-inferiority margin of 2%, i.e. the quit rate in the TTM group will be no worse than 2% less than the quit rate in the SQL group. Secondary outcomes will include self-reported continuous and point prevalence abstinence and acceptability and cost-effectiveness of TTM versus SQL.
Should the tailored text-message support prove non-inferior and more cost-effective than Quitline for this population, this will provide an opportunity for the upscaling of an effective, inexpensive and tailored quit support service. The trial findings will inform cessation treatment policy for priority populations in Australia and globally.
吸烟方面存在显著的不平等现象，社会经济地位低（低SES）人群的吸烟率更高。针对低SES吸烟人群量身定制的基于技术的项目有可能广泛覆盖，但需要大规模试验的有效性数据。这项针对来自低SES背景的澳大利亚吸烟者的试验将确定与标准戒烟热线（SQL）电话支持服务相比，量身定制的短信（TTM）支持的有效性和成本效益。
设计、地点与参与者：这是一项双臂、平行组、随机、非劣效性试验，在新南威尔士州大悉尼地区的澳大利亚人群中进行，采用分配隐藏和盲法结局评估。参与者为每天吸烟的成年人（n = 1246），有戒烟意愿且目前正在领取政府养老金或津贴，将通过广告招募。
参与者将按1:1比例随机分组，接受为期12个月的TTM戒烟支持或加入SQL电话支持。
评估将在随机分组后的基线（电话访谈）、1个月内（跟进电话）、3个月时（在线问卷）和12个月时（电话访谈）完成。主要结局将是在12个月随访时通过一氧化碳呼气试验验证的6个月持续戒烟情况。该研究将通过2%的非劣效性界值检验TTM是否不劣于SQL，即TTM组的戒烟率不比SQL组低2%以上。次要结局将包括自我报告的持续和点流行率戒烟情况以及TTM与SQL的可接受性和成本效益。
如果针对该人群的量身定制的短信支持被证明不劣于戒烟热线且更具成本效益，这将为扩大有效的、低成本且量身定制的戒烟支持服务提供机会。试验结果将为澳大利亚和全球优先人群的戒烟治疗政策提供参考。
