A randomized clinical trial of a financial education intervention with nicotine replacement therapy (NRT) for low socio-economic status Australian smokers: a study protocol
A randomized clinical trial of a financial education intervention with nicotine replacement therapy (NRT) for low socio-economic status Australian smokers: a study protocol
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DOI：
10.1111/add.12669
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发表时间：
2014-10-01
期刊：
影响因子：
6
通讯作者：
Mattick, Richard P.
中科院分区：
文献类型：
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作者：
Courtney, Ryan J.;Bradford, Deborah;Mattick, Richard P.
背景和目的降低低社会经济地位（SES）吸烟者的吸烟率是一项预防性卫生重点。经济压力（如缺钱或无力支付账单）可能是戒烟的主要障碍。本研究评估了金融教育和支持计划结合药物治疗在提高澳大利亚低社会经济地位吸烟者（接受政府养老金或津贴的人）8个月随访时戒烟率的效果。设计采用分组隐匿的两组平行区随机（比例1:1）开放标签临床试验（RCT）。分配将对数据收集点的采访者保密。本研究将主要通过电话进行，包括基线、后续访谈和电话支持会议。尼古丁替代疗法（NRT）的递送将以邮件为基础。参与者将通过报纸上的研究广告、政府社会援助机构的海报和戒烟热线电话戒烟支持服务来招募对戒烟感兴趣且目前正在接受政府福利的日常吸烟者（n=1046）。在完成基线计算机辅助电话访谈后，参与者将采用排列块方法随机分配到对照组或干预组。干预组和比较组的参与者将接受8周的免费NRT联合戒烟热线支持。干预组的参与者还将接受四次电话金融教育和支持课程。主要结局指标为延长禁欲（随访8个月），采用罗素标准进行评估，并经生化验证（尿可替宁）。这是第一项评估共同管理财务压力作为提高吸烟者戒烟能力的一种手段的潜力的干预研究。这种干预可能提供一个可扩展的干预，以帮助低社会经济地位的吸烟者戒烟。
Background and Aims Reducing smoking prevalence among smokers from low socio-economic status (SES) is a preventative health priority. Financial stress (e.g. shortage of money or inability to pay bills) may be a major barrier to quitting smoking. This study evaluates the efficacy of a financial education and support programme coupled with pharmacotherapy at improving cessation rates at 8-month follow-up among Australian low SES smokers (people receiving a government pension or allowance). Design A two-group parallel block randomized (ratio 1:1) open-label clinical trial (RCT) with allocation concealment will be conducted. Allocation will be concealed to interviewers at data collection-points. Setting The study will be conducted primarily by telephone with baseline, follow-up interviews and telephone-based support sessions. Nicotine replacement therapy (NRT) delivery will be mail-based. Participants Daily smokers who are interested in quitting smoking and are currently in receipt of government benefits (n=1046) will be recruited through study advertisements placed in newspapers, posters placed in government social assistance agencies and Quitline telephone-based cessation support services. After completion of a baseline computer-assisted telephone interview, participants will be allocated randomly to control or intervention group using a permuted block approach. Intervention and Comparator Participants in both groups will receive 8 weeks of free combination NRT plus Quitline support. Participants in the intervention group will also receive four telephone-delivered financial education and support sessions. Measurements The primary outcome measure will be prolonged abstinence (at 8-month follow-up) assessed using Russell Standard criteria and biochemically verified (urine cotinine). Comments This is the first intervention study to evaluate the potential of co-managing financial stress as a means of enhancing smokers' capacity to quit smoking. Such an intervention may provide a scalable intervention to help low SES smokers to quit.