Escape Smoke Project: Non-Intervention Non-Drug Multicenter Study on the Real-life Effectiveness of Smoking Cessation in General Practice in Denmark

Smoking Cessation Clinical Trial

— ESCAPE SMOKE  

Official title:

Escape Smoke Project: Non-Intervention Multicenter Study On the Real-Life Effectiveness of Smoking Cessation in General Practice in Denmark

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544621
• Other study ID #: A3051150
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: May 20, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unites States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40 General Practice (GP) centers with 800 smokers will participate.

Description:

Active smokers who wish to quit seen at in primary care practices

Recruitment information / eligibility

• Status: Completed
• Enrollment: 544
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Smoking males or females aged 18 years or older.

• Subjects being motivated for and willing to quit smoking.

• Ability to read and understand Danish.

Exclusion Criteria:

• Not smoking.

• Aged below 18 years.

• Lack of motivation and willingness to quit smoking.

• Do not read and understand Danish.

• Is not willing to cooperate with the clinic staff.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Smoking cessation
Smoking cessation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Technical University of Denmark (DTU)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Share of participants not smoking six months after the quit date. Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers		6 months	No
Secondary	Share of participants not smoking six months after the quit date Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)		6 months	No
Secondary	Share of participants at six months not smoking the last 14 days Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers		6 months	No
Secondary	Share of participants at six months not smoking the last 14 days Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)		6 months	No
Secondary	Share of participants not smoking at the last visit at the GP Intention-to-treat calculation, where participants lost to follow-up are included in as continued smokers		6 months	No
Secondary	Share of participants not smoking at the last visit at the GP. Per protocol calculation (participants lost to follow-up are excluded in the calculation of the quit rate)		6 months	No
Secondary	Share of participants still smoking at six months with a reduction in the use of tobacco and the resulting reduction in smoking Intention-to-treat calculation, where participants lost to follow-up are included in as continued		6 months	No

External Links

•   To obtain contact information for a study center near you, click here.