RSP: Effectiveness of Tobacco Cessation Interventions in Sweden

Sponsor
Lund University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04819152
Collaborator
(none)
8,000
8
43.7
1000
22.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tobacco cessation intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
8000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study
Actual Study Start Date :
Apr 9, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. % of patients that are continuously smokefree [6 months]

    Self-reported smoking status, questionnaire completed by telephone interview

Secondary Outcome Measures

  1. % of patients that are smokefree [On completion of the tobacco cessation programme (app. 1 month after quitting)]

    Counsellor observed smoking status, questionnaire completed by counsellor

  2. % of patients that have been smokefree for at least the latest 14 days [6 months]

    Self-reported smoking status, questionnaire completed by telephone interview

  3. % of patients that are satisfied with the smoking cessation intervention [6 months]

    Self-reported patient-satisfaction, questionnaire completed by telephone interview

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett Växjö Kronoberg Sweden
2 Capio Go Malmö Skåne Län Sweden
3 Livsstilsmedicin Österåsen Sollefteå Västernorrland Sweden
4 Ekeby Hälsocenter Uppsala Sweden
5 Flogsta vårdcentral Uppsala Sweden
6 Tobakspreventiva enheten, USÖ Örebro Sweden
7 Tybble vårdcentral Örebro Sweden
8 Tobakspreventiv mottagning Karlskoga Karlskoga Örebro Län Sweden

Sponsors and Collaborators

  • Lund University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Hanne Tonnesen, Professor, Lund University
ClinicalTrials.gov Identifier:
NCT04819152
Other Study ID Numbers:
  • Rökstoppsprojektet
  • Dnr: 2019-02221
  • 2017-01681
First Posted:
Mar 26, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hanne Tonnesen, Professor, Lund University

Study Results

No Results Posted as of Aug 18, 2022