Tobacco UseRSPNCT04819152
Effectiveness of Tobacco Cessation Interventions in Sweden
An observational study of Tobacco Use and Smoking, run by Lund University at 8 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking, Cigarette Use, Electronic
- What is being tested?
- Tobacco cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8,000 participants
- Where
- 8 sitesSweden
- Study dates
- 9 Apr 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population in this study are tobacco users in Sweden, who have attented an in-person tobacco cessation programme.
Who may be able to join
- 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.
Who cannot join
- Withdrawing consent.
- Reduced ability to give informed consent, due to inadequate language skills, dementia, and other conditions.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites, 8 recruiting
- Recruiting
Tobakspreventiv mottagning Karlskoga
Karlskoga, Örebro County
M Randén
- Recruiting
Capio Go
Malmö, Skåne County
A Karlsson
- Recruiting
Tobakspreventiva enheten, USÖ
Örebro
M Larsson
- Recruiting
Tybble vårdcentral
Örebro
M Larsson
- Recruiting
Livsstilsmedicin Österåsen
Sollefteå, Västernorrland County
A Mähler
A Stenius
- Recruiting
Ekeby Hälsocenter
Uppsala
K Brudin
- Recruiting
Flogsta vårdcentral
Uppsala
I Granlund
- Recruiting
Tobaksavvänjningen, Kirurgisk mott., CLV Växjö lasarett
Vaxjo, Kronoberg County
M Uneklint
About this study
Official title: Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study
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.
Read more
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).
- Conditions
- Tobacco Use, Smoking, Cigarette Use, Electronic
- Being tested
- Tobacco cessation intervention
- Keywords
- National cohort study, Effectiveness, Tobacco use cessation, Smoking cessation, Vulnerable groups
- Medical subject headings
- Tobacco Use, Smoking, Vaping, Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco cessation interventionBehavioural
Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Tobacco cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients that are continuously smokefree
Self-reported smoking status, questionnaire completed by telephone interview
Measured: 6 months
Secondary outcomes (3)
% of patients that are smokefree
Counsellor observed smoking status, questionnaire completed by counsellor
Measured: 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
Self-reported smoking status, questionnaire completed by telephone interview
Measured: 6 months
% of patients that are satisfied with the smoking cessation intervention
Self-reported patient-satisfaction, questionnaire completed by telephone interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start9 Apr 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanne Tonnesen, Lund University
- Investigators
- Hanne Tønnesen, DSc, Principal investigator, Lund University, Clinical health promotion centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819152
- Sponsor's protocol ID
- Rökstoppsprojektet
- Other IDs
- Dnr: 2019-02221, 2017-01681, 2017
- Acronym
- RSP
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35078840
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tobacco Cessation Interventions for Different Groups of Users in Sweden: a National Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04819152
- Acronym / sponsor ID
- RSP / Rökstoppsprojektet
- Conditions
- Tobacco Use, Smoking, Cigarette Use, Electronic
- Keywords
- National cohort study, Effectiveness, Tobacco use cessation, Smoking cessation, Vulnerable groups
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Behavioral: Tobacco cessation interventionSeveral 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. |
| Unexposed | – | Behavioral: Tobacco cessation interventionIn each study the unexposed group will consist of tobacco user from the study cohort without the condition examined in the relevant study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this study are tobacco users in Sweden, who have attented an in-person tobacco cessation programme.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Withdrawing consent.
- Reduced ability to give informed consent, due to inadequate language skills, dementia, and other conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco cessation interventionAlready implemented in-person (including online meetings) tobacco cessation interventions in Sweden | Behavioural | Exposed, Unexposed |
Primary outcome
% of patients that are continuously smokefree
Time frame: 6 months
Self-reported smoking status, questionnaire completed by telephone interview
3 secondary outcomes
% of patients that are smokefree
Time frame: 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
Time frame: 6 months
% of patients that are satisfied with the smoking cessation intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 35078840Rasmussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Tønnesen, DSc principal investigator
Lund University, Clinical health promotion centre
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use and Smoking, run by Lund University at 8 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette Rasmussen, PhD (+4538163850, mette.rasmussen@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients that are continuously smokefree (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.