Evaluation of the "Stop Tabac" Android phone application
| ISRCTN | ISRCTN17964518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17964518 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/06/2015
- Registration date
- 02/07/2015
- Last edited
- 30/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Schanzeneckstrasse 1
Bern
3001
Switzerland
 ORCID ID |
0000-0001-9603-5790 |
|---|
Study information
| Study design | A two-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy of a new smoking-cessation phone application : a randomized trial. |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 24/06/2015 |
| Completion date | 17/05/2017 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 6000 (3000 intervention group; 3000 control group) |
| Key inclusion criteria | 1. Adults (+18) 2. Smokers 3. Having approved the information and consent form 4. Willing to use the Android phone application |
| Key exclusion criteria | 1. Minors (-18) 2. Non-smokers 3. Not approved the information and consent form 4. Not having an Android smartphone |
| Date of first enrolment | 17/11/2015 |
| Date of final enrolment | 17/11/2016 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
1211 Genève 20
Geneva
1211
Switzerland
Sponsor information
University/education
Schanzeneckstrasse 1
Bern
3001
Switzerland
| Website | http://www.kpm.unibe.ch/content/index_eng.html |
|---|---|
"ROR" |
https://ror.org/02k7v4d05 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 17/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Editorial Notes
30/03/2016: Ethics approval information added.
04/12/2015: The overall trial dates have been updated from 17/07/2015-17/07/2016 to 24/06/2015-17/05/2017 and recruitment dates have been updated from 17/07/2015-17/07/2016 to 17/11/2015-17/11/2016.
