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

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

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

Condition or disease Intervention/treatment
Smoking Cessation Other: Smoking cessation

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

Study Type : Observational
Actual Enrollment : 544 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Escape Smoke Project: Non-Intervention Multicenter Study On the Real-Life Effectiveness of Smoking Cessation in General Practice in Denmark
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Successful quitters Sustained smokers
Successful quitters
Other: Smoking cessation
Smoking cessation



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Active smokers who wish to quit
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544621


Sponsors and Collaborators
Pfizer
Technical University of Denmark (DTU)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01544621     History of Changes
Other Study ID Numbers: A3051150
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Pfizer:
Real life smoking cessation. NON-drug NON-intervention study