Extrait

Background and study aims Nicotine replacement therapy (NRT) has been shown to be effective at helping people quit smoking in numerous clinical trials. However, the effectiveness of quit attempts with NRT purchased over-the-counter (OTC) is very low in the UK, which may be due to poor adherence to guidelines on NRT use. Therefore, stop smoking interventions focused on the use of OTC NRT could also increase the quit rates. Smartphone-based interventions delivered through applications, or apps, could be used to deliver support both for smoking cessation as well as NRT use as part of a quit attempt. However, to date no such intervention has been developed or evaluated. This study aims to test if a new app that was developed by researchers at University College London (UCL) and which focused on the use of NRT as part of a quit attempt could increase abstinence from smoking and use of NRT. The performance of the app will be compared with a reduced version of the app that offers only a minimal support with planning and monitoring of the quit attempt and brief advice on quitting, but which does not have features and extensive advice dedicated to smoking cessation and use of NRT. Who can participate? Adults aged at least 18, currently smoking at least 10 cigarettes per day, and who live in the UK. They should also have bought any nicotine replacement therapy (e.g., gums or sprays) over the counter, and be interested in stopping smoking completely in the next 2 weeks, and be able to use a new app for iPhone to help them. What does the study involve? The study compares two versions of an app for quitting smoking with NRT (either a single product, or a combination of a patch with another nicotine product, such as gums or sprays). When participants download the app and register into the study the app randomly allocates them to one of its two 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 quitting smoking and use of nicotine replacement therapy that might help them in their attempt to stop smoking. The user can also monitor their progress in terms of for how many days they have stopped smoking. The app also sends users reminders to use the app that can be disabled. Version 2 (intervention) offers the same features as version 1. In addition, it also provides comprehensive advice on smoking cessation (including information on craving management, preparation of quit attempt, and the available cessation support). It also includes an extensive suite of interactive features and comprehensive advice to assist with use of NRT products selected by participants, including text-based guides, and tools for monitoring of daily NRT use, and feedback on NRT use. 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 and use NRT as recommended. After 8 weeks participants are asked some questions via the app, and are contacted by e-mail and phone if they do not respond via the app. They are contacted again 7 months since registration by email, and if they do not respond then also by phone with few questions. At 8 weeks since the registration, participants who report that they have not smoked in the previous 4 weeks will be invited to provide small samples of saliva via post. Some participants may be 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 with NRT. Participants invited to provide saliva samples will receive a gift voucher of £20. Participants may experience some withdrawal symptoms such as irritability or increased hunger when they try to quit smoking. Those who are using NRT may also experience some side effects, but these tend to be short-lived and not dangerous. When is the study starting and how long is it expected to run for? March 2015 to March 2016 Where is the study run from? The study is conducted remotely on smartphones in the UK, and is managed by researchers at Health Behaviour Research Centre at University College London (UK) Who is funding the study? 1. Pfizer (through a grant award scheme, GRAND, that is run by a panel of independent scientists with no decision-making input from Pfizer) 2. British Heart Foundation PhD Studentship (UK) Who is the main contact? 1. Miss Aleksandra Herbec (Trial Lead) [email protected] 2. Tobias Raupach (Principal Investigator) [email protected]

Critère d'inclusion

• Cigarette Smoking

Liens

• ictrp
• isrctn