Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 25, 2018
Date Accepted: Nov 24, 2018
(closed for review but you can still tweet)
A Randomised Controlled Trial of a Novel Smoking Cessation Smartphone Application Integrated with a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Study Protocol
ABSTRACT
Background:
Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, continuous abstinence rate (CAR) from weeks nine to 12 is still about 50%. Recently, a smartphone application emerged as a novel tool for therapeutic interventions including nicotine dependence. In this study, we developed the ‘CureApp Smoking Cessation (CASC)’, which consists of a smartphone application for patients and a web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of smoking cessation treatment.
Objective:
To evaluate whether the CASC is effective for individuals with nicotine dependence in addition to standard smoking cessation programs.
Methods:
This will be a randomised, sham-controlled, open-label, multi-centre trial. We will recruit participants with nicotine dependence, otherwise healthy adults. We will randomise and allocate participants 1:1 to the CASC treatment group or sham-application control group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counselling. In addition, participants in the treatment group will have the CASC application installed in their smartphone, which provides video tutorials, advice from an artificial intelligence nurse, a digital diary, and measurements of daily exhaled CO concentration. In contrast, the control group will have the sham-application installed in their smartphone, in which all the functions that can have potential effects on smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks nine to 24. Success of smoking cessation will be defined as 1) self-reported continuous abstinence from weeks nine to 24, and 2) exhaled CO concentration ≤10 ppm both at weeks 12 and 24. Main secondary outcomes will be as follows: CAR from weeks nine to 12 and weeks nine to 52; and 7-day point prevalence abstinence at weeks four, eight, 12, 24, and 52.
Results:
We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019.
Conclusions:
This is the first randomised controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has significantly higher CAR from weeks nine to 24 compared to the sham-control application. Clinical Trial: The University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN ID: UMIN000031589).
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