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:
Collaborator:
Technical University of Denmark (DTU)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01544621
First received: February 29, 2012
Last updated: May 20, 2013
Last verified: May 2013
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544621

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01544621     History of Changes
Other Study ID Numbers: A3051150
Study First Received: February 29, 2012
Last Updated: May 20, 2013
Health Authority: Unites States: Food and Drug Administration

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 24, 2014