Effectiveness of Tobacco Cessation Interventions in Sweden (RSP)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Smoking; Tobacco Use; Cigarette Use, Electronic
• Intervention / Treatment: Behavioral: Tobacco cessation intervention

• Study Type: Observational
• Enrollment (Anticipated): 8000

Contacts and Locations

• Study Contact: Name: Mette Rasmussen, PhD; Phone Number: +4538163850; Email: mette.rasmussen@med.lu.se
• Study Contact Backup: Name: Hanne Tønnesen, DSc; Phone Number: +46724531481; Email: hanne.tonnesen@med.lu.se

Study Locations

• Sweden
  • Uppsala, Sweden
    • Recruiting
    • Ekeby Hälsocenter
    • Contact: K Brudin
  • Uppsala, Sweden
    • Recruiting
    • Flogsta vårdcentral
    • Contact: I Granlund
  • Örebro, Sweden
    • Recruiting
    • Tobakspreventiva enheten, USÖ
    • Contact: M Larsson
  • Örebro, Sweden
    • Recruiting
    • Tybble vårdcentral
    • Contact: M Larsson
  • Kronoberg
    • Växjö, Kronoberg, Sweden
      • Recruiting
      • Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett
      • Contact: M Uneklint
  • Skåne Län
    • Malmö, Skåne Län, Sweden
      • Recruiting
      • Capio Go
      • Contact: A Karlsson
  • Västernorrland
    • Sollefteå, Västernorrland, Sweden
      • Recruiting
      • Livsstilsmedicin Österåsen
      • Contact: A Mähler
      • Contact: A Stenius
  • Örebro Län
    • Karlskoga, Örebro Län, Sweden
      • Recruiting
      • Tobakspreventiv mottagning Karlskoga
      • Contact: M Randén

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed; Several studies will be performed based on this cohort. I each study the exposed group will be a group of tobacco users evaluatedin the relevant study. This could be a vulnarable group tobacco users such as: users without a job, with short or no education, without permanent housing, diagnosed with mental illness, diagnosed with chronic obstructive pulmonary disease (COPD), undergoing surgery, adolescents, elderly, migrants, or pregnant women.	Behavioral: Tobacco cessation intervention; Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden
Unexposed; In each study the unexposed group will consist of tobacco user from the study cohort without the condition examined in the relevant study.	Behavioral: Tobacco cessation intervention; Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% of patients that are continuously smokefree	Self-reported smoking status, questionnaire completed by telephone interview	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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)
% of patients that have been smokefree for at least the latest 14 days	Self-reported smoking status, questionnaire completed by telephone interview	6 months
% of patients that are satisfied with the smoking cessation intervention	Self-reported patient-satisfaction, questionnaire completed by telephone interview	6 months

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Hanne Tønnesen, DSc, Lund University, Clinical health promotion centre

Publications and helpful links

General Publications

• 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.

Helpful Links

• The Swedish national public homepage of the project

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Smoking cessation; Effectiveness; Tobacco use cessation; National cohort study; Vulnerable groups
• Other Study ID Numbers: Rökstoppsprojektet; Dnr: 2019-02221 (Other Identifier: Etikprövningsmyndigheten); 2017-01681 (Other Grant/Funding Number: FORTE)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No