NCT04819152

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

March 23, 2021

Last Update Submit

August 16, 2022

Conditions

Keywords

National cohort studyEffectivenessTobacco use cessationSmoking cessationVulnerable groups

Outcome Measures

Primary Outcomes (1)

  • % of patients that are continuously smokefree

    Self-reported smoking status, questionnaire completed by telephone interview

    6 months

Secondary Outcomes (3)

  • % of patients that are smokefree

    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

    6 months

  • % of patients that are satisfied with the smoking cessation intervention

    6 months

Study Arms (2)

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

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

Interventions

Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden

ExposedUnexposed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population in this study are tobacco users in Sweden, who have attented an in-person tobacco cessation programme.

You may qualify if:

  • Both individual and group-based interventions can be included.

You may not qualify if:

  • Withdrawing consent.
  • Reduced ability to give informed consent, due to inadequate language skills, dementia, and other conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett

Vaxjo, Kronoberg County, Sweden

RECRUITING

Capio Go

Malmo, Skåne County, Sweden

RECRUITING

Livsstilsmedicin Österåsen

Sollefteå, Västernorrland County, Sweden

RECRUITING

Tobakspreventiva enheten, USÖ

Örebro, Sweden

RECRUITING

Tybble vårdcentral

Örebro, Sweden

RECRUITING

Ekeby Hälsocenter

Uppsala, Sweden

RECRUITING

Flogsta vårdcentral

Uppsala, Sweden

RECRUITING

Tobakspreventiv mottagning Karlskoga

Karlskoga, Örebro County, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35078840BACKGROUND

MeSH Terms

Conditions

Tobacco UseSmokingVapingTobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Hanne Tønnesen, DSc

    Lund University, Clinical health promotion centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Rasmussen, PhD

CONTACT

Hanne Tønnesen, DSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

April 9, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 18, 2022

Record last verified: 2022-08

Locations