Tobacco Use Clinical Trial
Official title:
Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.
| 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 |
| Verified date | June 2022 |
| Source | Vastra Gotaland Region |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Vastra Gotaland Region |
| 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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