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Effectiveness of Tobacco Cessation Interventions in Sweden (RSP)

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ClinicalTrials.gov Identifier: NCT04819152
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : August 18, 2022
Sponsor:
Information provided by (Responsible Party):
Hanne Tonnesen, Lund University

Tracking Information
First Submitted Date March 23, 2021
First Posted Date March 26, 2021
Last Update Posted Date August 18, 2022
Actual Study Start Date April 9, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2021)
% of patients that are continuously smokefree [ Time Frame: 6 months ]
Self-reported smoking status, questionnaire completed by telephone interview
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2021)
  • % of patients that are smokefree [ Time Frame: On completion of the tobacco cessation programme (app. 1 month after quitting) ]
    Counsellor observed smoking status, questionnaire completed by counsellor
  • % of patients that have been smokefree for at least the latest 14 days [ Time Frame: 6 months ]
    Self-reported smoking status, questionnaire completed by telephone interview
  • % of patients that are satisfied with the smoking cessation intervention [ Time Frame: 6 months ]
    Self-reported patient-satisfaction, questionnaire completed by telephone interview
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Tobacco Use
  • Smoking
  • Cigarette Use, Electronic
Intervention Behavioral: Tobacco cessation intervention
Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden
Study Groups/Cohorts
  • 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.
    Intervention: Behavioral: Tobacco cessation intervention
  • Unexposed
    In each study the unexposed group will consist of tobacco user from the study cohort without the condition examined in the relevant study.
    Intervention: Behavioral: Tobacco cessation intervention
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2021)
8000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mette Rasmussen, PhD +4538163850 mette.rasmussen@med.lu.se
Contact: Hanne Tønnesen, DSc +46724531481 hanne.tonnesen@med.lu.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04819152
Other Study ID Numbers Rökstoppsprojektet
Dnr: 2019-02221 ( Other Identifier: Etikprövningsmyndigheten )
2017-01681 ( Other Grant/Funding Number: FORTE )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Hanne Tonnesen, Lund University
Original Responsible Party Same as current
Current Study Sponsor Lund University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Hanne Tønnesen, DSc Lund University, Clinical health promotion centre
PRS Account Lund University
Verification Date August 2022