Tobacco UseNCT05409963
Tobacco Impact on Quality of Life on Snus-use, Dual Use, Smoke Use and Non-using.
An observational study of Tobacco Use, run by Vastra Gotaland Region.
Trial summary
The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tobacco Use
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2010to 1 Mar 2014
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Three thousand women and men were randomly selected by the Swedish population data-base (SPAR) in rural areas of southwest Sweden.
Who may be able to join
- Age 18 to 65 years
Who cannot join
- not understand the Swedish language
About this study
Official title: Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.
The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers.
Read the detailed description
Tobacco use is a major public health issue. The number of smokers decrease simultaneously as oral moist snuff (called "snus"), is promoted as a healthier alternative in spite its' negative health effects. Studies of health-related quality of life (HRQOL) of those who use snuff are lacking. Recruitment of 674 women and 605 men aged 18 to 65 years through a Swedish population data-base was performed for this cross-sectional study in southwestern Sweden. Subjects completed a questionnaire about tobacco use and the 36-item Short Form Health Survey (SF-36). The non-parametric Mann-Whitney test was used for statistical analysis.
- Conditions
- Tobacco Use
- Keywords
- Cigarette smoking, Health, Population characteristics, Quality of life, Tobacco smokeless.
- Medical subject headings
- Tobacco Use, Cigarette Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life was measured using SF-36.
The SF-36 collected data on perceived health status in eight domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). The physical component summary (PCS) and mental component summary (MCS). Scores range from 0 to 100 with higher scores representing a higher perceived health
Measured: The time when the data entry is made, about 8 weeks
Tobacco habits.
The term pack-year (numbers of cigarettes / day * number of years / 20) and box-year (numbers of snuff boxes / week * number of years) was used to describe tobacco use. The variables smoking and snuff use were transformed from one pack-year to pack-decades by dividing pack-year by 10. Similarly, box-years were transformed to box-decades and age from years to decades.
Measured: The time when the data entry is made, about 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start18 Nov 2010
- Primary completion1 Mar 2012
- Study completion1 Mar 2014
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 Vastra Gotaland RegionThe 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
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Solbrith Wachsmann, Vastra Gotaland Region
- Investigators
- Solbrith Wachsmann, DMPhil, Study director, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, SwedenGun Rembeck, PHD, Principal investigator, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409963
- Sponsor's protocol ID
- 65381
- Status last verified
- Jun 2022
- First submitted
- 25 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wachsmann S, Nordeman L, Billhult A, Rembeck G. Tobacco impact on quality of life, a cross-sectional study of smokers, snuff-users and non-users of tobacco. BMC Public Health. 2023 May 15;23(1):886. doi: 10.1186/s12889-023-15844-z.
PubMed 37189128
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.
- ClinicalTrials.gov ID
- NCT05409963
- Acronym / sponsor ID
- 65381
- Conditions
- Tobacco Use
- Keywords
- Cigarette smoking, Health, Population characteristics, Quality of life, Tobacco smokeless.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 18 Nov 2010 (actual)
- Primary completion
- 1 Mar 2012 (actual)
- Study completion
- 1 Mar 2014 (actual)
- First posted
- 8 Jun 2022 (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.
The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers.
Detailed description
Tobacco use is a major public health issue. The number of smokers decrease simultaneously as oral moist snuff (called "snus"), is promoted as a healthier alternative in spite its' negative health effects. Studies of health-related quality of life (HRQOL) of those who use snuff are lacking. Recruitment of 674 women and 605 men aged 18 to 65 years through a Swedish population data-base was performed for this cross-sectional study in southwestern Sweden. Subjects completed a questionnaire about tobacco use and the 36-item Short Form Health Survey (SF-36). The non-parametric Mann-Whitney test was used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Three thousand women and men were randomly selected by the Swedish population data-base (SPAR) in rural areas of southwest Sweden.
Key inclusion criteria (1 listed)
- Age 18 to 65 years
Key exclusion criteria (1 listed)
- not understand the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life was measured using SF-36.
Time frame: The time when the data entry is made, about 8 weeks
The SF-36 collected data on perceived health status in eight domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). The physical component summary (PCS) and mental component summary (MCS). Scores range from 0 to 100 with higher scores representing a higher perceived health
Tobacco habits.
Time frame: The time when the data entry is made, about 8 weeks
The term pack-year (numbers of cigarettes / day * number of years / 20) and box-year (numbers of snuff boxes / week * number of years) was used to describe tobacco use. The variables smoking and snuff use were transformed from one pack-year to pack-decades by dividing pack-year by 10. Similarly, box-years were transformed to box-decades and age from years to decades.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 37189128Wachsmann S, Nordeman L, Billhult A, Rembeck G. Tobacco impact on quality of life, a cross-sectional study of smokers, snuff-users and non-users of tobacco. BMC Public Health. 2023 May 15;23(1):886. doi: 10.1186/s12889-023-15844-z.
- Individual participant dataSharing planned: No
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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.
Solbrith Wachsmann, DMPhil study director
Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
Gun Rembeck, PHD principal investigator
Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use, run by Vastra Gotaland Region.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life was measured using SF-36. (time frame: The time when the data entry is made, about 8 weeks). The study lists 2 primary outcomes in all. 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 NCT05409963, 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 8 Jun 2022.