Condition category
Mental and Behavioural Disorders
Date applied
22/09/2011
Date assigned
14/10/2011
Last edited
22/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tobacco smoking is the leading avoidable cause of death in high-income countries. As this impacts primarily the least educated and least affluent groups, a smoking cessation treatment that works well for those groups is needed. Research shows that offering financial incentives help increase both participation in smoking cessation programs and quit rates in those enrolled, at least in the short term (6 months). What is not known is whether financial incentives can enhance longer-term (1 year) smoking cessation rates, outside clinical and workplace settings. The objective of this study is to assess whether financial incentives of 1500 CHF (1600 USD, 1200 Euros, 1000 GBP) work. The study will also test whether 6-month effects translate into sustained abstinence 12 months after the incentives are withdrawn, and examine whether the outcome is influenced by the characteristics of participants (socio-demographics, level of tobacco dependence, motivation to quit, smoking history). Combining financial incentives and Internet-based counselling is an innovative approach that, if it is acceptable and works well, could be later implemented on a large scale at a reasonable cost, and save many lives.

Who can participate?
All adult daily smokers of 5 or more cigarettes/day, who earn <30,000 CHF for single taxpayers and <95,000 CHF for married taxpayers (these threshold corresponds to the 35% less affluent people in Geneva).

What does the study involve?
Two groups will be compared: group 1 will receive a smoking cessation program including: a) financial incentives of up to 1500 Frs and b) Internet-based counselling. Group 2 (control group) will receive only the online counselling but no financial incentives.

What are the possible benefits and risks of participating?
In the intervention group, financial rewards will be offered for biochemically verified smoking abstinence (carbon monoxide and cotinine) after 1, 2 and 3 weeks and after 1, 3 and 6 months (these milestones are called time points), for a maximum of 1500 CHF for those abstinent at all time points. All participants will receive Internet-based, customised smoking cessation counselling and self-help booklets, but there will be no in-person or telephone counselling, and participants will not receive medications. There is no known risk.

Where is the study run from?
The study is carried out at the Faculty of Medicine of the University of Geneva, Switzerland

When is the study starting and how long is it expected to run for?
The first participant was enrolled in August 2011 and enrollment will last for 18 months

Who is funding the study?
The Tobacco Prevention Fund of the Swiss Federal Office of Public Health, Switzerland

Who is the main contact?
Dr Jean-François Etter
Jean-Francois.Etter@unige.ch

Trial website

http://www.stop-tabac.ch/1500/

Contact information

Type

Scientific

Primary contact

Dr Jean-Francois Etter

ORCID ID

Contact details

Institut de Medecine Sociale et Preventive
Faculte de Medecine
Universite de Geneve
1 rue Michel-Servet
Geneva
1211
Switzerland
+41 (0)22 379 04 59
Jean-Francois.Etter@unige.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HUG 11-040

Study information

Scientific title

Financial incentives for smoking cessation in low-income smokers: a randomized trial

Acronym

Study hypothesis

A smoking cessation program including:
Financial incentives of up to 1500 CHF (1550 USD, 1150 Euros, 960 GBP) given during 6 months and Internet-based counselling will increase smoking cessation rates in low-income smokerscompared with a control group receiving the online counselling but no financial incentives

Ethics approval

Geneva University Hospitals Ethics Committee, 06/04/2011, ref: HUG 11-040

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

http://www.stoptabac.ch/fr/brochure/incitations_financieres01_quadri.pdf

Condition

Smoking, tobacco dependence, nicotine addiction

Intervention

Financial incentives of up to 1500 CHF (1550 USD, 1150 Euros, 960 GBP) given during 6 months for the interventional group with internet-based counselling will increase smoking cessation rates in low-income smokers, compared with a control group receiving the online counselling but no financial incentives.

Follow-up and verification of abstinence after 3 and 6 months (end of intervention) and after 18 months (=12 months after the end of intervention).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Continuous smoking abstinence between 6 and 18 months, that is, self-report of no puff of tobacco in the previous 7 days at 6 months plus self-report of no smoking between the 6 and 18-month surveys, not contradicted by CO, cotinine and thiocyanate measurements.

Secondary outcome measures

1. Biochemically confirmed point prevalence of abstinence after 3, 6 and 18 months
2. Abstinence at 3, 6 and 18 months using the "Russell Standard", a recently suggested standard for smoking cessation trials
3. Quit attempts during the intervention phase (number, duration and dates)
4. Cigarette consumption, motivation to quit, confidence in ability to quit
5. Use of the online smoking cessation program

Overall trial start date

15/08/2011

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. >18 years old
2. Taxable income <30,000 CHF for single taxpayers and <95,000 CHF for married taxpayers, proven by most recent fiscal taxation
3. Smokes at least 5 cigarettes per day, every day
4. Has smoked for at least 1 year
5. Baseline CO reading of at least 10 ppm
6. Baseline saliva cotinine reading of NicAlert level 1 or higher (>=10 ng/mL)
7. Sets a quit date within one month and commits to quit at that date by signing the quit contract
8. Commits to take part in all follow-up surveys and in all biochemical tests of abstinence
9. Declares to understand and to accept the control group procedure
10. Signs informed consent form at each line
11. Shows identity document with photo (a copy will be kept in our records)
12. Has regular access to Internet and e-mail
13. Commits to read e-mail daily during the study
14. Valid e-mail address, postal address and telephone number

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1050

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/08/2011

Recruitment end date

31/03/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

Universite de Geneve
Geneva
1211
Switzerland

Sponsor information

Organisation

University of Geneva (Switzerland)

Sponsor details

c/o Mr Jean-François Etter
Institut de Medecine Sociale et Preventive
Faculte de Medecine
1
rue Michel-Servet
Geneva
1211
Switzerland
+41 (0)22 379 04 59
Jean-Francois.Etter@unige.ch

Sponsor type

University/education

Website

http://www.stop-tabac.ch/1500/

Funders

Funder type

Government

Funder name

Tobacco Prevention Fund, Swiss Federal Office of Public Health (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22721577
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27539168

Publication citations

  1. Protocol

    Etter JF, Financial incentives for smoking cessation in low-income smokers: study protocol for a randomized controlled trial., Trials, 2012, 13, 88, doi: 10.1186/1745-6215-13-88.

  2. Results

    Etter JF, Schmid F, Effects of Large Financial Incentives for Long-Term Smoking Cessation: A Randomized Trial, J Am Coll Cardiol, 2016 , 68, 8, 777-785, doi: 10.1016/j.jacc.2016.04.066.

Additional files

Editorial Notes

22/08/2016: Publication reference added.