RCT Results of Smoking Cessation Using a Smartphone App: A Q&A with Kenichiro Nishii

By Jeff Craven /alert Contributor
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Smoking cessation smartphone apps have the potential to help adults who want to quit smoking. However, to date, there have been few studies examining the efficacy of this treatment resource. Kenichiro Nishii, lead of the Clinical & Regulatory Affairs Division at CureApp, recently discussed the results of their CureApp Smoking Cessation application, which were presented at the 2019 American Thoracic Society International Conference in Dallas.


Woman using smartphone. Source: Getty

How can a smartphone app help with smoking cessation?

The app can improve smoking cessation rates by providing continuous support to a patient and clinical guidance to a health care provider (HCP). The app is connected to CureApp cloud system that stores the patient’s profile, conditions, CO level, as well as clinical insights from the HCP from the initial counselling. Based on the inputs, the cloud system generates personalized guidance for the patient and clinical guidance for the HCP to aid counselling.

How does the carbon monoxide checker in CureApp Smoking Cessation (CASC) operate?

The CO Checker incorporates an electrochemical sensor to detect the breath CO level of a patient. The CO level helps our system and HCP to understand the patient's smoking behavior so that they can improve the clinical guidance. It allows the healthcare provider to personalize and adjust their advice based on patient's smoking behavior. The CO Checker aids the feedback with objective continuous data where there was only patient's self-reported data available previously. The device wirelessly pairs with the mobile app and automatically sends the CO level for each measurement taken every day.

How was the trial designed? What intervention did the CASC group receive compared with the control group?

The study design is a randomized, sham-controlled, open-label, multicenter trial with 580 participants. Both treatment and control groups received a 12-week standard smoking cessation program with pharmacotherapy and counselling. The treatment group used the CASC app, which provides personalized real-time guidance exhaled based on the patient activity and the CO level. The control group used a control app installed in which all the functions that can potentially affect smoking cessation were removed.

The primary outcome is the biochemically validated continuous abstinence rate from weeks 9-24. The success of smoking cessation was defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration <10 ppm both at weeks 12 and 24. The main secondary outcomes was the continuous abstinence rate (CAR) from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52.

The reason behind this study design was due to lack of RCT phase III trial conducted anywhere in the world. We aimed to obtain the first comparison with a strong clinical study design.

What were the results of the study?

The result from the trial showed that the difference in CAR between CureApp CASC and the conventional treatment was 14.4% at 52 weeks, and 13.2% for varenicline vs placebo, indicating comparable efficacy of our solution to pharmacological approach. (10.1001/jama.296.1.56). Also, the phase III clinical trial for other conditions including diabetes, pediatric ADHD, and substance abuse existed previously, but this is the first digital therapeutic smoking cessation.

Additionally, the digital therapeutics can treat phycological dependence, which is not addressed with current medications. The app can also be prescribed to those who are not treated with current medication, including pregnant patients and patients with severe mental illness.

How can clinicians use the results of this study in clinical practice?

Clinicians in not only smoking cessation field but also in other fields of medicine who advise patients to stop smoking can take advantage of this. Clinicians in various field including cardiology, diabetes, and family medicine often advice smokers to quit smoking due to its negative health effect. Although even brief advice helps patients quit smoking, it has been difficult for clinicians to provide further interventions. Improved clinical outcome with an automated system enables them to provide continuous support for smokers without increasing the physicians’ workload.


Reference:

Tateno H, et al. Am J Respir Crit Care Med. 2019;199:A7357.

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