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面向俄克拉荷马州烟草帮助热线用户的基于智能手机的戒烟干预措施(OKquit):一项随机对照试验的方案

Smartphone-Based Smoking Cessation Intervention (OKquit) for Oklahoma Tobacco Helpline Users: Protocol for a Randomized Controlled Trial.

作者信息

Businelle Michael, Becerra Jessica, Witten Carl, Chen Sixia, Kezbers Krista, Beebe Laura A, Kendzor Darla E

机构信息

TSET Health Promotion Research Center, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.

Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.

出版信息

JMIR Res Protoc. 2024 Aug 1;13:e56827. doi: 10.2196/56827.

DOI:10.2196/56827
PMID:39088254
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11327626/
Abstract

BACKGROUND

Tobacco quitlines provide effective resources (eg, nicotine replacement therapy, smoking cessation counseling, and text and web-based support) for those who want to quit smoking in the United States. However, quitlines reach approximately only 1%-3% of people who smoke each year. Novel, smartphone-based, and low-burden interventions that offer 24/7 access to smoking cessation resources that are tailored to current readiness to quit may increase appeal, reach, and effectiveness of smoking cessation interventions.

OBJECTIVE

This study will examine the efficacy of OKquit, a low-burden smartphone-based app for smoking cessation.

METHODS

Approximately 500 people who smoke cigarettes and access the Oklahoma Tobacco Helpline (OTH) will be randomized to receive standard OTH care (SC) or SC plus the novel OKquit smartphone app for smoking cessation (OKquit). All participants will use a smartphone app to complete study surveys (ie, baseline, 27 weekly surveys, brief daily check-ins, and 27-week follow-up). Upon completion of daily check-ins and weekly surveys, participants will receive either trivia type messages (SC) or messages that are tailored to current readiness to quit smoking and currently experienced lapse triggers (OKquit). In addition, those assigned to receive the OKquit app will have access to on-demand smoking cessation content (eg, quit tips, smoking cessation medication tips). It is hypothesized that participants assigned to OKquit will be more likely to achieve biochemically verified 7-day point prevalence abstinence than those assigned to SC at 27 weeks post enrollment. In addition, participants who use more OTH resources (eg, more cessation coaching sessions completed) or more OKquit resources (eg, access more quit tips) will have greater biochemically verified smoking cessation rates.

RESULTS

Data collection began in September 2022 and final follow-ups are expected to be completed by May 2025.

CONCLUSIONS

Data from this randomized controlled trial will determine whether the OKquit smartphone app combined with OTH care will increase smoking cessation rates over standard OTH care alone. If successful, OKquit could provide tailored intervention content at a fraction of the cost of traditional interventions. Furthermore, this type of low-burden intervention may offer a way to reach underserved populations of adults who smoke and want to quit.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05539209; https://clinicaltrials.gov/study/NCT05539209.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56827.

摘要

背景

戒烟热线为美国那些想要戒烟的人提供了有效的资源(如尼古丁替代疗法、戒烟咨询以及基于文本和网络的支持)。然而,戒烟热线每年仅能覆盖约1% - 3%的吸烟者。基于智能手机且负担较低的新型干预措施,能提供全天候获取根据当前戒烟意愿量身定制的戒烟资源,这可能会提高戒烟干预措施的吸引力、覆盖面和有效性。

目的

本研究将考察OKquit这款基于智能手机的低负担戒烟应用程序的疗效。

方法

约500名吸烟且拨打俄克拉荷马州戒烟热线(OTH)的人将被随机分为两组,一组接受标准的OTH护理(SC),另一组接受标准OTH护理加新型OKquit智能手机戒烟应用程序(OKquit)。所有参与者将使用智能手机应用程序完成研究调查(即基线调查、27次每周调查、简短的每日签到以及27周的随访)。在完成每日签到和每周调查后,参与者将收到琐事类信息(SC组)或根据当前戒烟意愿及当前经历的复吸触发因素量身定制的信息(OKquit组)。此外,被分配接受OKquit应用程序的人将可以获取按需提供的戒烟内容(如戒烟小贴士、戒烟药物小贴士)。据推测,在入组27周后,被分配到OKquit组的参与者比被分配到SC组的参与者更有可能实现经生化验证的7天点流行率戒断。此外,使用更多OTH资源(如完成更多戒烟辅导课程)或更多OKquit资源(如获取更多戒烟小贴士)的参与者将有更高的经生化验证的戒烟率。

结果

数据收集于2022年9月开始,最终随访预计于2025年5月完成。

结论

这项随机对照试验的数据将确定OKquit智能手机应用程序与OTH护理相结合是否会比单独的标准OTH护理提高戒烟率。如果成功,OKquit可以以传统干预措施成本的一小部分提供量身定制的干预内容。此外,这种低负担干预措施可能为接触到服务不足的成年吸烟且想戒烟人群提供一种途径。

试验注册

ClinicalTrials.gov NCT05539209;https://clinicaltrials.gov/study/NCT05539209。

国际注册报告标识符(IRRID):DERR1-10.2196/56827。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/fb163e3948ec/resprot_v13i1e56827_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/10db3afd19ad/resprot_v13i1e56827_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/5bcabd850f4b/resprot_v13i1e56827_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/fb163e3948ec/resprot_v13i1e56827_fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/10db3afd19ad/resprot_v13i1e56827_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/5bcabd850f4b/resprot_v13i1e56827_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6578/11327626/fb163e3948ec/resprot_v13i1e56827_fig3.jpg

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