Cigarette smoking Mental and Behavioural Disorders Stopping smoking
Conditions
Interventions
Participants are randomized to either an intervention or control version of the quitting smoking app with randomization embedded in the registration process in the App. Both conditions provide partici
www.sf28.co.uk). In the development process Bupa has purchased a non-exclusive perpetual licence to SF28 source code to develop it further, and based on it two versions of the app were developed: an i
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/05/2016: 1. Currently living in the UK 2. 18 years or older 3. A daily smoker 4. Willing to set a Quit Date and try to make a serious quit attempt in the next 2 weeks 5. Have regular access to a smartphone (iOS or Android) with access to internet 6. Download and try using the suggested App to help them quit 7. Agree to be contacted via the App, e-mail or telephone at 4 weeks and 6 months after the Quit Date 8. Agree to, if invited, to remotely confirm abstinent status with a personal carbon monoxide monitor that will be posted to you for free Participants also have to provide informed consent to participate in the study, agree to End User Licence Agreement for BupaQuit set by Bupa, and complete the registration into the trial via the App. Previous inclusion criteria: 1. Currently living in the UK 2. 18 years or older 3. A regular daily smoker (at least 5 cigarettes/day) 4. Willing to set a Quit Date and try to make a serious quit attempt in the next 2 weeks 5. Have regular access to a smartphone (iOS or Android) with access to the internet 6. Download and try using the suggested App to help them quit 7. Agree to be contacted via the app, e-mail or telephone at 4 weeks and 6 months after the Quit Date 8. If invited, agree to remotely confirm abstinence status with a personal carbon monoxide monitor that will be posted to participants for free. Participants also have to provide informed consent to participate in the study, agree to End User Licence Agreement & Privacy Policy for the app set by Bupa, and complete the registration into the trial via the app.
Exclusion criteria
Exclusion criteria: 1. Does not meet inclusion criteria 2. Only data from the first registration will be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/05/2016: The primary outcome will be self-report of not smoking in the two weeks prior to the follow up scheduled for 4 weeks. Smokers lost to follow up will be presumed to have resumed smoking, as per intention-to-treat principle. Note: participants with missing data on the exact scheduled Quit Date will be followed-up 5 weeks and 195 days since their registration. Previous primary outcome measures: The primary outcome will be self-report of not smoking in the two weeks prior to the follow up scheduled for 4 weeks, and biochemically verified by a reading of <10ppm CO at the 4-week follow up. Smokers lost to follow up will be presumed to have resumed smoking, as per intention-to-treat principle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/05/2016: Secondary outcomes assessed at 4-week follow-up since the quit date: 1. Self-reported complete abstinence rates during the 2 weeks prior to follow up scheduled for 4 weeks after the target quit date biochemically and remotely verified by a reading of <10ppm on personal CO monitors 2. Self-reported use of cessation medications and other support at 4-week follow-up 3. Satisfaction ratings of the intervention at 4 week follow up, including ratings of app helpfulness to manage cravings (scale 1-5) 4. Ratings of acceptability and ease of use of the personal CO monitoring devices, as well as time since last cigarette (measured in weeks) assessed through CO monitoring software (prepared by Bedfont Scientitic Ltd for the purpose of the current trial) Secondary outcomes and process data collected by the App throughout the trial: 5. Quantitative indices of App use (number of times the App) 6. Craving levels reported (scale 0-4) in the first week of use 7. Self-reported smoking status during App use 8. Ratings of helpfulness of individual components in the intervention version of the App Secondary outcomes assessed at 6-month follow-up since the quit date (participants were contacted at 6 months and 2 weeks to account for a ‘grace period’ of the first 2 weeks since quit date): 9. Russell Standard (RS6) self-reported continuous 6-month abstinence, defined as having no more than 5 cigarettes in the past 6 months and no cigarettes in the previous week (self-reported rates; and rates verified by carbon monoxide levels in the exhaled air <10ppm) 10. 7-day point-prevalence abstinence at 6-month follow-up (self-reported rates; and rates verified by carbon monoxide levels in the exhaled air <10ppm) The CO mon | — |
Countries
England, United Kingdom
Contacts
Public ContactAlex Matei
Outcome results
None listed