Plain English Summary
Background and study aims
The health issue studied here is stopping smoking (smoking cessation). Self-help methods for smoking cessation can be inexpensive methods that work well and can be made accessible to many people. New technologies can be used as self-help supports. We would like to test how well a new smoking cessation smartphone application called Stop-Tabac works at getting people to kick the habit.
Who can participate?
All adult smokers willing to use a phone application can participate to the study.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention) receive the real smoking cessation smartphone application. Those in group 2 (control) receive a placebo (smartphone application with minimal content on stopping smoking). All participants are asked to complete online questionnaires at the start of the study, 3 months after the study starts and then at 6 months.
What are the possible benefits and risks of participating?
The benefits of participating in the study is the possibility of the participant receiving the real phone application, and the chance of taking part in a scientific research aimed at assisting smokers to stop smoking. The risks of participating in the study is that a participant may be assigned to the placebo phone application. However, the use of any other kind of smoking cessation aid is allowed during the study.
Where is the study run from?
Institute of Global Health, University of Geneva (Switzerland)
When is the study starting and how long is it expected to run for?
July 2015 to July 2016
Who is funding the study?
Tobacco Control Fund of the Swiss Federal Office of Public Health
Who is the main contact?
Mrs Céline Mavrot
celine.mavrot@kpm.unibe.ch
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Céline Mavrot
ORCID ID
http://orcid.org/0000-0001-9603-5790
Contact details
Schanzeneckstrasse 1
Bern
3001
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of a new smoking-cessation phone application : a randomized trial.
Acronym
Study hypothesis
13.5% of the phone application users quit smoking after 6 months vs. 11% of the placebo phone application users quit smoking after 6 months
Ethics approval
The ethic board Kantonale Ethikkommission Bern (KEK) declared on 19/02/2015 that this study did not require an approval of the competent ethics commission (the KEK).
Study design
A two-group randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Smoking cessation
Intervention
1. Intervention group of the randomized trial: receives the real smoking cessation smartphone application
2. Control group of the randomized trial: receives a placebo smoking cessation smartphone application (minimal content)
Intervention type
Device
Phase
Drug names
Primary outcome measures
Primary outcome: smoking/not smoking, measured by self-administrated online questionnaires, completed at baseline, after 3 months and after 6 months.
Secondary outcome measures
N/A
Overall trial start date
24/06/2015
Overall trial end date
17/05/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults (+18)
2. Smokers
3. Having approved the information and consent form
4. Willing to use the Android phone application
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
6000 (3000 intervention group; 3000 control group)
Participant exclusion criteria
1. Minors (-18)
2. Non-smokers
3. Not approved the information and consent form
4. Not having an Android smartphone
Recruitment start date
17/11/2015
Recruitment end date
17/11/2016
Locations
Countries of recruitment
Switzerland
Trial participating centre
Institute of Global Health, University of Geneva
9 Chemin des Mines
1211 Genève 20
Geneva
1211
Switzerland
Sponsor information
Organisation
Center of Competence for Public Management - University of Berne
Sponsor details
Schanzeneckstrasse 1
Bern
3001
Switzerland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Tobacco Control Fund of the Swiss Federal Office of Public Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The authors from Universities Bern and of Geneva have planned to publish the results on the efficacy of the Stop-Tabac smartphone application in a scientific journal specialized in the field of addictions.
Intention to publish date
17/05/2018
Participant level data
Not expected to be available
Results - basic reporting
Publication summary