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
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 April 14, 2014