Clinical trial NCT04819152: Effectiveness of Tobacco Cessation Interventions in Sweden
Official title: Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tobacco Use
Smoking
Cigarette Use, Electronic
Keywords: National cohort study
Effectiveness
Tobacco use cessation
Smoking cessation
Vulnerable groups
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population in this study are tobacco users in Sweden, who have attented an in-person tobacco cessation programme.

Brief summary: Smoking is still one of the most important risk factors causing morbidity and mortality in Sweden. Every year, 12,000 Swedish citizens die prematurely from smoking, and smoking is responsible for up to 60% of the inequity in health.

Though the smoking prevalence is relatively low in Sweden in an international context (8% and 10% for men and women respectively in 2016), specific vulnarable groups have a very high prevalence; e.g. about 80% in alcohol and drug abusers. Furthermore, Sweden has a unique high prevalence of snus users and in 2016 the daily use of tobacco was 25% for men and 14% for women. In addition, products such as cigarettes, snus, and e-cigettes are often mixed.

Despite the fact that about a thousand counsellors have been trained in manual-based person-centred tobacco cessation interventions in Sweden, the effectiveness of the interventions remains unknown, as a follow-up on effect of in-person interventions is not systematically collected in Sweden. Therefore, as of today it is not possible, on a national level, to compare the effectiveness of differences in these interventions, providers, or different groups of tobacco users including disadvantaged and vulnerable groups.

In this study the investigators will evaluate the effectiveness of already implemented in-person cessation interventions targeting smoking, use of snus and/or e-cigarettes, focusing on disadvantaged and vulnerable groups of tobacco users. Furthermore, important factors associated with a successful outcome after controlling for confounders will be identified (in relation to programme, patients and setting).


Eligibility criteria: Inclusion Criteria:

* All adult tobacco users (of at least 18 years of age), including disadvantaged and vulnerable patients, receiving an in-person intervention (incl. online meetings) for tobacco cessation (smoking, snus and/or e-cigarettes) are eligible for inclusion in the project after giving informed consent.
* Both individual and group-based interventions can be included.

Exclusion Criteria:

* Withdrawing consent.
* Reduced ability to give informed consent, due to inadequate language skills, dementia, and other conditions.

Primary outcomes:
measure: % of patients that are continuously smokefree
timeFrame: 6 months
Secondary outcomes:
measure: % of patients that are smokefree
timeFrame: On completion of the tobacco cessation programme (app. 1 month after quitting)
measure: % of patients that have been smokefree for at least the latest 14 days
timeFrame: 6 months
measure: % of patients that are satisfied with the smoking cessation intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett
state: Kronoberg
city: Malmö
country: Sweden
facility: Capio Go
state: Skåne Län
city: Sollefteå
country: Sweden
facility: Livsstilsmedicin Österåsen
state: Västernorrland
city: Uppsala
country: Sweden
facility: Ekeby Hälsocenter
city: Uppsala
country: Sweden
facility: Flogsta vårdcentral
city: Örebro
country: Sweden
facility: Tobakspreventiva enheten, USÖ
city: Örebro
country: Sweden
facility: Tybble vårdcentral
city: Karlskoga
country: Sweden
facility: Tobakspreventiv mottagning Karlskoga
state: Örebro Län
Study officials:
affiliation: Lund University, Clinical health promotion centre
name: Hanne Tønnesen, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen M, Larsson M, Gilljam H, Adami J, Warjerstam S, Post A, Bjork-Eriksson T, Helgason AR, Tonnesen H. Effectiveness of tobacco cessation interventions for different groups of tobacco users in Sweden: a study protocol for a national prospective cohort study. BMJ Open. 2022 Jan 25;12(1):e053090. doi: 10.1136/bmjopen-2021-053090.