Pivot Health Technologies Inc., San Carlos, CA, United States.
Department of Pediatrics, University of North Carolina, Chapel Hill, NC, United States.
JMIR Mhealth Uhealth. 2022 Nov 24;10(11):e41658. doi: 10.2196/41658.
Cigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment.
This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute.
In this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples.
Participants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot.
In this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program.
ClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.
吸烟仍然是可预防的疾病和死亡的主要原因，这突显了对基于循证解决方案的持续需求。Pivot 是一个基于美国临床实践指南的移动戒烟程序，包括个人一氧化碳呼气传感器；智能手机应用程序；应用程序内、基于文本的人工提供指导；尼古丁替代疗法；以及一个经过 moderation 的基于网络的社区。有前途的 Pivot 队列研究为比较评估奠定了基础。
本研究旨在比较 Pivot 和 QuitGuide（美国国家癌症研究所基于美国临床实践指南的戒烟智能手机应用程序）在参与度、保留率、戒烟态度、吸烟行为和参与者反馈方面的差异。
在这项远程试点随机对照试验中，美国的吸烟者在网上招募，并随机分配到 Pivot 或 QuitGuide。参与者提供了 12 周的免费尼古丁替代疗法。数据通过每周一次的在线问卷在 12 周和 26 周时进行自我报告。结果包括参与度和保留率、戒烟态度、吸烟行为和参与者反馈。主要结果是 12 周时自我报告的应用程序打开次数。戒烟结果包括自我报告的 7 天和 30 天的点流行率戒烟（PPA）、所有烟草产品的戒烟和 12 周和 26 周的连续戒烟。PPA 和连续戒烟通过呼吸一氧化碳样本进行生物验证。
参与者包括 188 名吸烟者（94 名 Pivot 和 94 名 QuitGuide）：平均年龄 46.4（SD 9.2）岁，104 名（55.3%）女性，128 名（68.1%）白人，平均每天吸烟 17.6（SD 9.0）支。通过“12 周内总应用程序打开次数”（主要结果）衡量的参与度为 Pivot，157.9（SD 210.6）与 QuitGuide，86.5（SD 66.3；P<.001）。12 周和 26 周时自我报告的 7 天 PPA 分别为 Pivot，35%（33/94）与 QuitGuide，28%（26/94；意向治疗[ITT]：P=.28）和 Pivot，36%（34/94）与 QuitGuide，27%（25/94；ITT：P=.12）。12 周和 26 周时自我报告的 30 天 PPA 分别为 Pivot，29%（27/94）与 QuitGuide，22%（21/94；ITT：P=.32）和 Pivot，32%（30/94）与 QuitGuide，22%（21/94；ITT：P=.12）。12 周时生物验证的戒烟率分别为 Pivot，29%（27/94）与 QuitGuide，13%（12/94；ITT：P=.008）。26 周时生物验证的连续戒烟率分别为 Pivot，21%（20/94）与 QuitGuide，10%（9/94；ITT：P=.03）。参与者的反馈，包括设置的易用性、对吸烟的影响以及对计划推荐的可能性，都对 Pivot 表示肯定。
在这项比较基于应用程序的戒烟程序 Pivot 和 QuitGuide 的随机对照试验中，Pivot 参与者在 12 周和 26 周时的参与度更高，生物验证的戒烟率更高，用户反馈也更好。这些发现支持 Pivot 作为一种有效的、持久的移动戒烟程序。
ClinicalTrials.gov NCT04955639；https://clinicaltrials.gov/ct2/show/NCT04955639。
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