Tobacco Impact on Quality of Life on Snus-use, Dual Use, Smoke Use and Non-using.

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Completed
CT.gov ID
NCT05409963
Collaborator
(none)
3,000
39.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.
    Actual Study Start Date :
    Nov 18, 2010
    Actual Primary Completion Date :
    Mar 1, 2012
    Actual Study Completion Date :
    Mar 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Health-related quality of life was measured using SF-36. [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

    2. Tobacco habits. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Age 18 to 65 years

    Exclusion Criteria:

    not understand the Swedish language

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    • Study Director: Solbrith Wachsmann, DMPhil, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
    • Principal Investigator: Gun Rembeck, PHD, Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Solbrith Wachsmann, Specialist nurse, phil,mag, Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT05409963
    Other Study ID Numbers:
    • 65381
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Solbrith Wachsmann, Specialist nurse, phil,mag, Vastra Gotaland Region

    Study Results

    No Results Posted as of Jun 8, 2022