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Effectiveness of Tobacco Cessation Interventions in Sweden (RSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Tobacco Use Smoking Cigarette Use, Electronic Behavioral: Tobacco cessation intervention

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Study Type : Observational
Estimated 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 : April 9, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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




Primary Outcome Measures :
  1. % of patients that are continuously smokefree [ Time Frame: 6 months ]
    Self-reported smoking status, questionnaire completed by telephone interview


Secondary Outcome Measures :
  1. % 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

  2. % 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

  3. % of patients that are satisfied with the smoking cessation intervention [ Time Frame: 6 months ]
    Self-reported patient-satisfaction, questionnaire completed by telephone interview



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819152


Contacts
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Contact: Mette Rasmussen, PhD +4538163850 mette.rasmussen@med.lu.se
Contact: Hanne Tønnesen, DSc +46724531481 hanne.tonnesen@med.lu.se

Locations
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Sweden
Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett Recruiting
Växjö, Kronoberg, Sweden
Contact: M Uneklint         
Capio Go Recruiting
Malmö, Skåne Län, Sweden
Contact: A Karlsson         
Livsstilsmedicin Österåsen Recruiting
Sollefteå, Västernorrland, Sweden
Contact: A Mähler         
Contact: A Stenius         
Ekeby Hälsocenter Recruiting
Uppsala, Sweden
Contact: K Brudin         
Flogsta vårdcentral Recruiting
Uppsala, Sweden
Contact: I Granlund         
Tobakspreventiva enheten, USÖ Recruiting
Örebro, Sweden
Contact: M Larsson         
Tybble vårdcentral Recruiting
Örebro, Sweden
Contact: M Larsson         
Tobakspreventiv mottagning Karlskoga Recruiting
Karlskoga, Örebro Län, Sweden
Contact: M Randén         
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Hanne Tønnesen, DSc Lund University, Clinical health promotion centre
Additional Information:
Publications:
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Responsible Party: Hanne Tonnesen, Professor, Lund University
ClinicalTrials.gov Identifier: NCT04819152    
Other Study ID Numbers: Rökstoppsprojektet
Dnr: 2019-02221 ( Other Identifier: Etikprövningsmyndigheten )
2017-01681 ( Other Grant/Funding Number: FORTE )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanne Tonnesen, Lund University:
National cohort study
Effectiveness
Tobacco use cessation
Smoking cessation
Vulnerable groups