Extrait

Background and study aims Smartphone-based interventions (in the form of applications or apps) have the potential to help smokers quit smoking. Additionally, due to their being highly assessible, apps could offer users with constant support with managing sudden cravings for cigarettes. Craving cigarettes is one of the main reasons why people start up smoking again once they have stopped. However, there still isn’t enough evidence to show that apps do help people quit smoking or whether they work in helping people manage their cravings for cigarettes. This study aims to test if a new app developed by researchers at University College London (UCL) and Bupa, can successfully help people to stop smoking. This app focuses on helping smokers with manage their craving for cigarettes on a moment to moment basis. The performance of the app will be compared with a reduced version that offers only a minimal support with planning and monitoring of the quit attempt, and brief advice, but which does not have features and extensive advice dedicated to craving management. Who can participate? Adults aged at least 18, are currently smoking at least 5 cigarettes per day, and live in the UK. They should also be interested in stopping smoking in the next 2 weeks and be able to use a new app for Android or iPhone to help. What does the study involve? The study assesses different tools for quitting smoking available within two versions of a new app for quitting smoking. When participants download the app and join the study the app randomly allocates them to one of its versions, which they will then use to support them though an attempt to quit smoking. Version 1 of the app (control) allows users to set up the date to quit (within two weeks of joining the study) and provides brief information on medications and lifestyle changes that might help them in their attempt to stop smoking. The user can monitor their progress in terms of for how many days they have stopped smoking, how much money they have saved and gives feedback on successful abstinence on a daily basis or on lapse into smoking. The app also sends users reminders to use the app that can be disabled, and lets them share their progress (number of smoke-free days) on social media or e-mail. Version 2 (intervention) offers the same features as version 1. It also provides an extensive suit of features, advice and an interactive “gaming” element that aim to provide assistance with managing cravings for cigarettes on a moment-to-moment basis. These includes feedback on the level of cravings and encouragement to use stop smoking medication, particularly nicotine replacement therapy in case of higher craving levels, and statistics the cravings reported. The app also offers a ‘toolbox’ of craving aids that includes distraction activities (e.g. game), motivational content (video diaries of smokers, and text-based stories and information), challenges and exercises known to support craving management (for example deep breathing exercises), relaxation audio-recordings with meditation and music. Version 2 also offers a system of point collection through app use that gradually unlocks some of the craving management content. All participants in both groups select a quit date within 2 weeks of signing up to the study after which they try to quit smoking completely, using the app as a support tool. After 4 weeks, each participant is asked some questions via the app and are contacted by phone if they don’t respond to the app. They are contacted again 6 months later by email and then by phone with a few questions. Participants that report that they have stopped smoking 4 weeks into the study and then after 6 months may be invited to take part in a remote measurement of the level of carbon monoxide (CO) in their exhaled air. This test is done using a personal carbon monoxide monitor that is posted free of charge. Some participants are invited to a follow-up interview study about their experiences with the app. What are the possible benefits and risk of participating? By taking part in the study, participants are more likely to quit smoking, which would be one of the most beneficial things that one can do to improve health. They will also receive access to a new and free app for quitting smoking that will also help them to monitor their craving levels. Participants invited to take part in the remote CO measurement can keep the device for personal use in the future. Participants may experience some withdrawal symptoms such as irritability or increased hunger when they try to quit smoking. When is the study starting and how long is it expected to run for? July 2014 to August 2016 Where is the study run? The study is conducted remotely on smartphones in the UK, and is managed by Bupa and researchers at University College London (UK) Who is funding the study? 1. Bupa (UK) 2. British Heart Foundation (UK) Who is the main contact? Miss Aleksandra Herbec [email protected]

Critère d'inclusion

• Cigarette Smoking

Liens

• isrctn
• ictrp