Condition category
Mental and Behavioural Disorders
Date applied
24/06/2015
Date assigned
02/07/2015
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.kpm.unibe.ch/content/index_eng.html

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

Publication citations

Additional files

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.