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Register:	ISRCTN
Last refreshed on:	20 June 2023
Main ID:	ISRCTN11318024
Date of registration:	17/05/2018
Prospective Registration:	Yes
Primary sponsor:	University of Geneva
Public title:	Impact of a smartphone application on smoking cessation: a randomized controlled trial
Scientific title:	Impact of a smartphone application on smoking cessation: a randomized controlled trial
Date of first enrolment:	10/04/2019
Target sample size:	5200
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN11318024
Study type:	Interventional
Study design:	Two-arm parallel-group individually randomized “placebo”-controlled trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Switzerland

Contacts

Name:	Jean-François Etter
Address:	ISG-Campus Biotech 9 ch. des Mines 1202 Geneva Switzerland
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Daily cigarette smoker
2. Has been a daily smoker for at least one year
3. >18 years old
4. Sets a target quit date within one month of enrollment and commits to quit on this date
5. Provides informed consent online
6. Commits to answer all follow-up questionnaires, and commits to use the app
7. Owns a smartphone with Android operating system and has regular access to the Internet
8. Provides a postal address and telephone number, and a valid e-mail address
9. Lives in Switzerland or in France

Exclusion criteria: Prior use of the Stop-tabac app for smartphones (self-report)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cigarette smoking
Mental and Behavioural Disorders
Mental and behavioural disorders due to use of tobacco

Intervention(s)

The trialists will randomly assign 5200 smokers to either using the Stop-tabac application for smartphones for 6 months or to use a placebo application. Stop-tabac is a fully-automated application (“app”) for smartphones that includes:
1. Immediate feedback during episodes of craving and tobacco withdrawal symptoms
2. An interactive “coach” that provides individually-tailored counseling messages based on responses to a questionnaire (personal profile). These automated messages are sent regularly during 6 months
3. A discussion forum (“The Tribe”) where participants receive support from other users
4. Fact sheets; a calculator of cigarettes not smoked, money saved, and years of life gained
5. A module on nicotine replacement therapy that includes personalized feedback
Follow-up after 1 week, 1 month and 6 months.

Primary Outcome(s)

Self-reported smoking cessation at 6 months (no puff of tobacco in the past 4 weeks). All data will be self-reported via online questionnaires. Participants can use any device to answer (smartphone, tablet, laptop, desktop). There will be no biochemical validation of smoking status. Assessed 4 times: at baseline, and 1 week, 1 month and 6 months after the participant’s target smoking cessation date.

Secondary Outcome(s)

1. Point prevalence of smoking abstinence at 6 months (no puff of tobacco in the previous 7 days)
2. Russell Standard (<5 cigarettes in the past 6 months plus no puff of tobacco in the past 7 days)
3. Abstinence of any tobacco and e-cigarette use at 6 months (no use in the previous 7 days)
4. Motivation to quit
5. Quit attempts (number and duration)
6. Confidence in ability to quit
7. Use of nicotine therapy
8. Use of e cigarettes and heated tobacco products

All data will be self-reported via online questionnaires. Participants can use any device to answer (smartphone, tablet, laptop, desktop). There will be no biochemical validation of smoking status. Assessed 4 times: at baseline, and 1 week, 1 month and 6 months after the participant’s target smoking cessation date.

Secondary ID(s)

SNF 320030_179369

Source(s) of Monetary Support

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Received confirmation that ethics committee approval is not needed 16/05/2018, Commission Cantonale d'Ethique de la Recherche (CCER) (Rue Adrien-Lachenal 8, 1207 Geneva, Switzerland; messaging@basec.swissethics.ch), ref: Req-2018-00356.

Results

Results available:	Yes
Date Posted:
Date Completed:	04/11/2020
URL:

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