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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05409963
Other study ID # 65381
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 18, 2010
Est. completion date March 1, 2014

Study information

Verified date June 2022
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date March 1, 2014
Est. primary completion date March 1, 2012
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Age 18 to 65 years Exclusion Criteria: not understand the Swedish language

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vastra Gotaland Region

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The time when the data entry is made, about 8 weeks
Primary 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. The time when the data entry is made, about 8 weeks
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