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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04819152
Other study ID # Rökstoppsprojektet
Secondary ID Dnr: 2019-022212
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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