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

• ClinicalTrials.gov Identifier: NCT01544621
• Recruitment Status: Completed
• First Posted: March 6, 2012
• Last Update Posted: May 21, 2013
• Sponsor: Pfizer
• Collaborator: Technical University of Denmark (DTU)
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: February 29, 2012
• First Posted Date: March 6, 2012
• Last Update Posted Date: May 21, 2013
• Study Start Date: November 2011
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 29, 2012): 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 [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 29, 2012)

• 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) [ Time Frame: 6 months ]
• 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 [ Time Frame: 6 months ]
• 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) [ Time Frame: 6 months ]
• 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 [ Time Frame: 6 months ]
• 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) [ Time Frame: 6 months ]
• 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 [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Escape Smoke Project: Non-Intervention Non-Drug Multicenter Study on the Real-life Effectiveness of Smoking Cessation in General Practice in Denmark
• Official Title: Escape Smoke Project: Non-Intervention Multicenter Study On the Real-Life Effectiveness of Smoking Cessation in General Practice in Denmark
• Brief Summary: Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40 General Practice (GP) centers with 800 smokers will participate.
• Detailed Description: Active smokers who wish to quit seen at in primary care practices
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Active smokers who wish to quit
• Condition: Smoking Cessation

Intervention

Other: Smoking cessation

Smoking cessation

Study Groups/Cohorts

Successful quitters Sustained smokers

Successful quitters

Intervention: Other: Smoking cessation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2013): 544
• Original Estimated Enrollment (submitted: February 29, 2012): 800
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01544621
• Other Study ID Numbers: A3051150
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Technical University of Denmark (DTU)

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: May 2013