Effectiveness of Tobacco Cessation Interventions in Sweden

Smoking Clinical Trial

— RSP  

Official title:

Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819152
• Other study ID #: Rökstoppsprojektet
• Secondary ID: Dnr: 2019-022212
• Status: Recruiting
• Start date: April 9, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Lund University
• Contact: Mette Rasmussen, PhD
• Phone: +4538163850
• Email: mette.rasmussen[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Use, Electronic
• Smoking
• Tobacco Use

Intervention

Behavioral:
• Tobacco cessation intervention
Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden

Locations

Country	Name	City	State
Sweden	Tobakspreventiv mottagning Karlskoga	Karlskoga	Örebro Län
Sweden	Capio Go	Malmö	Skåne Län
Sweden	Tobakspreventiva enheten, USÖ	Örebro
Sweden	Tybble vårdcentral	Örebro
Sweden	Livsstilsmedicin Österåsen	Sollefteå	Västernorrland
Sweden	Ekeby Hälsocenter	Uppsala
Sweden	Flogsta vårdcentral	Uppsala
Sweden	Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett	Växjö	Kronoberg

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Rasmussen M, Larsson M, Gilljam H, Adami J, Wärjerstam S, Post A, Björk-Eriksson T, Helgason AR, Tønnesen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of patients that are continuously smokefree	Self-reported smoking status, questionnaire completed by telephone interview	6 months
Secondary	% of patients that are smokefree	Counsellor observed smoking status, questionnaire completed by counsellor	On completion of the tobacco cessation programme (app. 1 month after quitting)
Secondary	% of patients that have been smokefree for at least the latest 14 days	Self-reported smoking status, questionnaire completed by telephone interview	6 months
Secondary	% of patients that are satisfied with the smoking cessation intervention	Self-reported patient-satisfaction, questionnaire completed by telephone interview	6 months

External Links

•   The Swedish national public homepage of the project