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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544621
First Posted: March 6, 2012
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Technical University of Denmark (DTU)
Information provided by (Responsible Party):
Pfizer
  Purpose
Real life smoking cessation rates after 24 weeks non-intervention design. Approximately 40 General Practice (GP) centers with 800 smokers will participate.

Condition Intervention
Smoking Cessation Other: Smoking cessation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 544
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Successful quitters Sustained smokers
Successful quitters
Other: Smoking cessation
Smoking cessation

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01544621     History of Changes
Other Study ID Numbers: A3051150
First Submitted: February 29, 2012
First Posted: March 6, 2012
Last Update Posted: May 21, 2013
Last Verified: May 2013

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