长期综合移动戒烟计划联合尼古丁替代疗法对成年吸烟者的影响：一项先导随机对照试验。

Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial.

机构信息

Pivot Health Technologies, Inc, San Carlos, CA, United States.

Department of Pediatrics, University of North Carolina, Chapel Hill, NC, United States.

出版信息

JMIR Mhealth Uhealth. 2023 Sep 18;11:e48157. doi: 10.2196/48157.

DOI:10.2196/48157

PMID:37585282

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10546267/

Abstract

BACKGROUND

Increased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability.

OBJECTIVE

The primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation.

METHODS

In this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation.

RESULTS

Participants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit.

CONCLUSIONS

This pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

摘要

背景

智能手机拥有量的增加推动了移动戒烟计划的发展。虽然通过随机对照试验（RCT）开展的相关证据数量在质量和严格程度上有所提高，但仍需要长期数据来评估与戒烟相关的持续率。

目的

本研究的主要目的是比较成年吸烟者在接受 Pivot（干预组）和 QuitGuide（对照组）移动戒烟计划后 52 周的戒烟结局。次要目的包括比较其他与吸烟相关的行为、结局和参与者反馈，并对与戒烟相关的基线因素进行探索性分析。

方法

在这项远程试点 RCT 中，通过网络在美国招募吸烟者。参与者可获得 12 周的免费尼古丁替代疗法（NRT）。通过基于网络的问卷，结合对报告 7 天点预戒烟（PPA）的参与者进行视频会议生物验证来报告数据。研究结果侧重于戒烟率，以及戒烟尝试、每天吸烟量（CPD）、戒烟自我效能感（通过吸烟 abstinence self-efficacy Questionnaire 评估）、NRT 使用和参与者反馈的评估。戒烟结局包括自我报告的 7 天和 30 天 PPA、所有烟草制品的戒烟以及连续戒烟。通过见证呼气一氧化碳样本对 PPA 和连续戒烟进行生物验证。进行了探索性事后回归分析，以确定与戒烟相关的基线变量。

结果

参与者包括 188 名吸烟者（n=94，50%在 Pivot 组，n=94，50%在 QuitGuide 组；平均年龄 46.4，SD 9.2 岁；n=104，55.3%女性；n=128，68.1%白种人；CPD 平均 17.6，SD 9.0）。在 Pivot 组（意向治疗），几种戒烟率更高：自我报告的连续戒烟率为 20%（19/94），而 QuitGuide 组为 9%（8/94；P=.03）；生物验证的戒烟率为 31%（29/94），而 QuitGuide 组为 18%（17/94；P=.04）；生物验证的连续戒烟率为 19%（18/94），而 QuitGuide 组为 9%（8/94；P=.046）。更多的 Pivot 参与者（93/94，99%对 80/94，85%在 QuitGuide 组；P<.001）下了 NRT 订单（Pivot 组平均 3.3，SD 2.0，QuitGuide 组 1.8，SD 1.6；P<.001）。Pivot 组参与者的戒烟自我效能感通过 Smoking Abstinence Self-Efficacy Questionnaire 有所提高（平均增加 3.2，SD 7.8，P<.001，而 QuitGuide 组为 1.0，SD 8.5，P=.26）。QuitGuide 组参与者的戒烟尝试次数更多（Pivot 组平均 7.0，SD 6.3，QuitGuide 组 9.5，SD 7.5；P=.01）。在未达到戒烟的参与者中，QuitGuide 组参与者报告的 CPD 减少量更大（Pivot 组平均 -34.6%，SD 35.5%，QuitGuide 组 -46.1%，SD 32.3%；P=.04）。在报告戒烟的参与者中，90%（35/39）的 Pivot 组参与者和 90%（26/29）的 QuitGuide 组参与者表示他们的戒烟计划帮助他们戒烟。