NCT01544621

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

February 29, 2012

Last Update Submit

May 20, 2013

Conditions

Smoking Cessation

Keywords

Real life smoking cessation. NON-drug NON-intervention study

Outcome Measures

Primary Outcomes (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

    6 months

Secondary Outcomes (6)

  • 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)

    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

    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)

    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

    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)

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Successful quitters Sustained smokers

Successful quitters

Other: Smoking cessation

Interventions

Smoking cessationOTHER

Smoking cessation

Successful quitters Sustained smokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Active smokers who wish to quit

You may qualify if:

  • Smoking males or females aged 18 years or older.
  • Subjects being motivated for and willing to quit smoking.
  • Ability to read and understand Danish.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 6, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 21, 2013

Record last verified: 2013-05