Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study

Marler, Jennifer D; Fujii, Craig A; Utley, David S.; Tesfamariam, Lydia J; Galanko, Joseph A.; Patrick, Heather

doi:10.2196/12609

Cited by 38 publications

(31 citation statements)

References 37 publications

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“…Compared with other digital therapeutic interventions, the 44.5% (118/265) and 52.4% (118/225) 7-day abstinence rates 4 weeks after the quit date (for ITT and PP, respectively) compare favorably with previous digital intervention studies. Pivot, another digital therapeutic intervention, achieved an end-of-study CO-verified 7-day abstinence rate of 32% (ITT) and 37% (PP) [ 20 ]. An acceptance and commitment therapy intervention by Smartquit achieved 21% 7-day abstinence at 2 months post enrollment [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Webb¹,

Peerbux²,

Smittenaar³

et al. 2020

JMIR Ment Health

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Background Tobacco smoking remains the leading cause of preventable death and disease worldwide. Digital interventions delivered through smartphones offer a promising alternative to traditional methods, but little is known about their effectiveness. Objective Our objective was to test the preliminary effectiveness of Quit Genius, a novel digital therapeutic intervention for smoking cessation. Methods A 2-arm, single-blinded, parallel-group randomized controlled trial design was used. Participants were recruited via referrals from primary care practices and social media advertisements in the United Kingdom. A total of 556 adult smokers (aged 18 years or older) smoking at least 5 cigarettes a day for the past year were recruited. Of these, 530 were included for the final analysis. Participants were randomized to one of 2 interventions. Treatment consisted of a digital therapeutic intervention for smoking cessation consisting of a smartphone app delivering cognitive behavioral therapy content, one-to-one coaching, craving tools, and tracking capabilities. The control intervention was very brief advice along the Ask, Advise, Act model. All participants were offered nicotine replacement therapy for 3 months. Participants in a random half of each arm were pseudorandomly assigned a carbon monoxide device for biochemical verification. Outcomes were self-reported via phone or online. The primary outcome was self-reported 7-day point prevalence abstinence at 4 weeks post quit date. Results A total of 556 participants were randomized (treatment: n=277; control: n=279). The intention-to-treat analysis included 530 participants (n=265 in each arm; 11 excluded for randomization before trial registration and 15 for protocol violations at baseline visit). By the quit date (an average of 16 days after randomization), 89.1% (236/265) of those in the treatment arm were still actively engaged. At the time of the primary outcome, 74.0% (196/265) of participants were still engaging with the app. At 4 weeks post quit date, 44.5% (118/265) of participants in the treatment arm had not smoked in the preceding 7 days compared with 28.7% (76/265) in the control group (risk ratio 1.55, 95% CI 1.23-1.96; P<.001; intention-to-treat, n=530). Self-reported 7-day abstinence agreed with carbon monoxide measurement (carbon monoxide <10 ppm) in 96% of cases (80/83) where carbon monoxide readings were available. No harmful effects of the intervention were observed. Conclusions The Quit Genius digital therapeutic intervention is a superior treatment in achieving smoking cessation 4 weeks post quit date compared with very brief advice. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 65853476; https://www.isrctn.com/ISRCTN65853476

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Section: Discussionmentioning

confidence: 99%

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Webb¹,

Peerbux²,

Smittenaar³

et al. 2020

JMIR Ment Health

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“…The app assessed by Iacoviello et al [ 16 ] has a series of missions and personalized messages that adhere to the United States Clinical Practice Guideline, and 26.2% of the ITT sample (109/416) reported 30-day abstinence from smoking after 8 weeks. Another study evaluated a comprehensive, multiphase digital smoking cessation program that includes a mobile carbon monoxide breath sensor and text-based human coaching and reported a 30-day point prevalence abstinence of 27.6% (88/319, ITT) [ 21 ]. The outcomes could have been strongly affected by the difference in the country the study was conducted in and ethnicity.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of the Ascure Smoking Cessation Program: Retrospective Study

Kato¹,

Tanigawa²,

Satake³

et al. 2020

JMIR Mhealth Uhealth

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Background Smoking cessation helps extend a healthy life span and reduces medical expenses. However, the standard 12-week smoking cessation program in Japan has several notable problems. First, only 30% of participants complete this program. Second, participants may choose not to participate unless they have a strong motivation to quit smoking, such as health problems. Third, the program does not provide enough support during the period between clinical visits and after 12 weeks. Objective This study examined the efficacy of the 24-week ascure program to address the problems of accessibility and continuous support. The program combines online mentoring, over-the-counter pharmacotherapy, and a smartphone app. Methods Using a retrospective study design, we investigated data for 177 adult smokers who were enrolled in the ascure smoking cessation program between August 2017 and August 2018. The primary outcomes were continuous abstinence rates (CARs) during weeks 9-12 and weeks 21-24. To confirm smoking status, we performed salivary cotinine testing at weeks 12 and 24. We also evaluated the program adherence rate. Finally, we performed exploratory analysis to determine the factors associated with continuous abstinence at weeks 21-24 to provide insights for assisting with long-term continuous abstinence. Results The CARs of all participants for weeks 9-12 and weeks 21-24 were 48.6% (95% CI 41.2-56.0) and 47.5% (95% CI 40.0-54.8), respectively. Program adherence rates were relatively high throughout (72% at week 12 and 60% at week 24). In the analysis of the factors related to the CAR at weeks 21-24, the number of entries in the app’s digital diary and number of educational videos watched during the first 12 weeks were significant factors. Conclusions The ascure program achieved favorable CARs, and participants showed high adherence. Proactive usage of the smartphone app may help contribute to smoking cessation success in the long-term.

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“…Marler et al [ 18 ] followed the aforementioned study with results in 319 smokers who underwent the complete Pivot program, which included a personal CO breath sensor, smartphone app, and in-app SMS text messaging–based human coaching. There were significant positive changes in attitudes during the prequit portion of the program, including increased confidence to quit ( P <.001) and decreased expected difficulty maintaining quit ( P <.001).…”

Section: Introductionmentioning

confidence: 99%

“…As a result, it is difficult to specifically identify the role of exhaled CO in reported motivation and smoking behavior outcomes. Moreover, with few exceptions [ 16 - 18 ], these exhaled CO measurements were obtained through health care providers or study personnel during study visits, with very few CO breath samples collected during these studies. It is, however, unclear how outcomes might differ when exhaled CO is regularly measured and tracked by smokers as personal biofeedback.…”

Section: Introductionmentioning

confidence: 99%

Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study

Marler¹,

Fujii²,

Wong³

et al. 2020

J Med Internet Res

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Background Tobacco use is the leading cause of preventable morbidity and mortality. Existing evidence-based treatments are underutilized and have seen little recent innovation. The success of personal biofeedback interventions in other disease states portends a similar opportunity in smoking cessation. The Pivot Breath Sensor is a personal interactive FDA-cleared (over-the-counter) device that measures carbon monoxide (CO) in exhaled breath, enabling users to link their smoking behavior and CO values, and track their progress in reducing or quitting smoking. Objective The objective of this study is to assess the Pivot Breath Sensor in people who smoke cigarettes, evaluating changes in attitudes toward quitting smoking, changes in smoking behavior, and use experience. Methods US adults (18-80 years of age, ≥10 cigarettes per day [CPD]) were recruited online for this remote 12-week study. Participants completed a screening call, informed consent, and baseline questionnaire, and then were mailed their sensor. Participants were asked to submit 4 or more breath samples per day and complete questionnaires at 1-4, 8, and 12 weeks. Outcomes included attitudes toward quitting smoking (Stage of Change, success to quit, and perceived difficulty of quitting), smoking behavior (quit attempts, CPD reduction, and 7-, 30-day point prevalence abstinence [PPA]), and use experience (impact and learning). Results Participants comprised 234 smokers, mean age 39.9 (SD 11.3) years, 52.6% (123/234) female, mean CPD 20.3 (SD 8.0). The 4- and 12-week questionnaires were completed by 92.3% (216/234) and 91.9% (215/234) of participants, respectively. Concerning attitude outcomes, at baseline, 15.4% (36/234) were seriously thinking of quitting in the next 30 days, increasing to 38.9% (84/216) at 4 weeks and 47.9% (103/215) at 12 weeks (both P<.001). At 12 weeks, motivation to quit was increased in 39.1% (84/215), unchanged in 54.9% (118/215), and decreased in 6.0% (13/215; P<.001). Additional attitudes toward quitting improved from baseline to 12 weeks: success to quit 3.3 versus 5.0 (P<.001) and difficulty of quitting 2.8 versus 4.3 (P<.001). Regarding smoking behavior, at 4 weeks, 28.2% (66/234) had made 1 or more quit attempts (≥1 day of abstinence), increasing to 48.3% (113/234) at 12 weeks. At 4 weeks, 23.1% (54/234) had reduced CPD by 50% or more, increasing to 38.5% (90/234) at 12 weeks. At 12 weeks, CPD decreased by 41.1% from baseline (P<.001), and 7- and 30-day PPA were 12.0% (28/234) and 6.0% (14/234), respectively. Concerning use experience, 75.3% (171/227) reported the sensor increased their motivation to quit. More than 90% (>196/214) indicated the sensor taught them about their CO levels and smoking behavior, and 73.1% (166/227) reported that seeing their CO values made them want to quit smoking. Conclusions Use of the Pivot Breath Sensor resulted in a significant increase in motivation to quit, a reduction in CPD, and favorable quit attempt rates. These outcomes confer increased likelihood of quitting smoking. Accordingly, the results support a role for biofeedback via personal CO breath sampling in smoking cessation. Trial Registration ClinicalTrials.gov NCT04133064; https://clinicaltrials.gov/ct2/show/NCT04133064

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Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study

Cited by 38 publications

References 37 publications

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Preliminary Outcomes of a Digital Therapeutic Intervention for Smoking Cessation in Adult Smokers: Randomized Controlled Trial

Efficacy of the Ascure Smoking Cessation Program: Retrospective Study

Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study

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