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Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack.

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ClinicalTrials.gov Identifier: NCT00228098
Recruitment Status : Unknown
Verified September 2005 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : September 28, 2005
Last Update Posted : September 28, 2005
Sponsor:
Collaborators:
Danish Heart Foundation
Hjernesagen
Funen County
Information provided by:
Odense University Hospital

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date September 28, 2005
Study Start Date  ICMJE February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
Smoking cessation rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack.
Official Title  ICMJE Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack. A Randomised Controlled Trial
Brief Summary

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Detailed Description

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Patients with stroke or transient ischemic attack are admitted to the department of neurology at Odense University hospital. Patient who are smokers on admission and age < 76 years, inhabitants in Funen County and with symptoms developed before admission will be offered participation in the study unless they have severe stroke, stroke more than 3 weeks before admission, other severe disease or unable to participate.

Study participants will be randomised to either usual short advise on smoking cessation or an intensive smoking cessation program. All participants will be followed-up for 6 months with regard to smoking habits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Stroke
  • Transient Ischemic Attack
Intervention  ICMJE Behavioral: Smoking cessation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 27, 2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age < 76 years
  • Inhabitant in Funen County
  • Acute stroke or transient ischemic attack
  • Symptoms with onset before admission
  • Current smoker on admission

Exclusion Criteria:

  • Severe stroke
  • Current stroke onset more than 3 weeks before admission
  • Other severe disease
  • Unable to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228098
Other Study ID Numbers  ICMJE VF 20040136
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Danish Heart Foundation
  • Hjernesagen
  • Funen County
Investigators  ICMJE
Principal Investigator: Søren Bak, MD, PhD Department of Neurology, Odense University Hospital. 5000 Odense C. Denmark
PRS Account Odense University Hospital
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP