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Smoking Cessation Interventions in Stroke Patients

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ClinicalTrials.gov Identifier: NCT01574001
Recruitment Status : Unknown
Verified April 2012 by Halina Sienkiewicz-Jarosz, Institute of Psychiatry and Neurology, Warsaw.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Halina Sienkiewicz-Jarosz, Institute of Psychiatry and Neurology, Warsaw

Brief Summary:
The primary objective of the present randomized controlled trial is to compare the effectiveness of three anti-smoking interventions of different intensities. It has been hypothesised that early follow-up visits facilitate post-stroke smoking cessation in patients hospitalized because of first-ever ischemic stroke.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Behavioral: Antismoking intervention with no early follow-up Behavioral: Antismoking intervention with minimal early follow-up Behavioral: Antismoking intervention with intensive early follow-up Not Applicable

Detailed Description:

BACKGROUND: It is well known, that continued smoking after stroke increases the risk of death and stroke recurrence within a few years after the first stroke. Searching for more efficient methods of antismoking interventions is therefore justified.

OBJECTIVES: The primary objective of the present study is to compare the effectiveness of three anti-smoking interventions of different intensities.

DESIGN: Randomized, controlled trial.

METHODS: Study participants will be recruited among patients of neurological clinics of Institute of Psychiatry and Neurology, hospitalized because of their first in a lifetime ischemic stroke. All stroke patients will be screened regarding their smoking status. The subjects will be patients smoking cigarettes immediately before their first-ever stroke, able to understand the research protocol procedures and able to cooperate during the investigation.

Antismoking interventions will be based on the "5A's" method. Study participants will be randomized to one of three interventions differing in follow-up intensity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antismoking intervention with minimal early follow-up
an intervention according to the "5A's" model with one follow-up visit within one week after discharge from the hospital; follow-up assessment will include two visits: 3 and 12 months after stroke
Behavioral: Antismoking intervention with minimal early follow-up
Anti-smoking intervention in line with the "5A's" method (Ask, Advice, Assess, Assist, Arrange follow-up. The intervention will be carried out 5-7 days after stroke, before the planned discharge from the hospital. Seven days after discharge from a stroke unit a brief telephone/personal advice will be given aimed to motivate patients to quit smoking; follow-up assessment will include two visits: 3 and 12 months after stroke

Active Comparator: Antismoking intervention with no early follow-up
an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke
Behavioral: Antismoking intervention with no early follow-up
an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke

Experimental: Antismoking intervention with intensive early follow-up
an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke
Behavioral: Antismoking intervention with intensive early follow-up
an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke




Primary Outcome Measures :
  1. Smoking cessation rate [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients smoking immediately prior to stroke
  • The first in the lifetime ischemic stroke
  • Ability to understand the research protocol procedures and cooperation during the investigation
  • Reported availability of and declaration to participate in follow-up
  • Informed consent to participate in the study

Exclusion Criteria:

  • Severe stroke
  • Stroke onset more than 3 weeks before admission
  • History of previous stroke with clinical symptoms
  • Hemorrhagic stroke
  • Diagnosis of dementia or presence of other neurological disease (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington's chorea, a previous subarachnoid haemorrhage, meningitis, cerebral trauma in an interview)

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): NCT01574001


Contacts
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Contact: Halina Sienkiewicz-Jarosz, M.D., PhD +48224582548 jarosz@ipin.edu.pl

Locations
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Poland
Institute of Psychiatry and Neurology Recruiting
Warsaw, Poland, 02-957
Contact: Will    +48224582548    neurol1@ipin.edu.pl   
Principal Investigator: Halina Sienkiewicz-Jarosz, M.D., PhD         
Sub-Investigator: Przemysław Bienkowski, M.D., Prof.         
Sub-Investigator: Magdalena Restel, M.D.         
Sponsors and Collaborators
Institute of Psychiatry and Neurology, Warsaw
Investigators
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Principal Investigator: Halina Sienkiewicz-Jarosz, M.D., PhD 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
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Responsible Party: Halina Sienkiewicz-Jarosz, Principal Investigator, Institute of Psychiatry and Neurology, Warsaw
ClinicalTrials.gov Identifier: NCT01574001    
Other Study ID Numbers: IPIN-01
UMO-2011/01/B/NZ7/05402 ( Other Grant/Funding Number: National Science Center, Poland )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: April 2012
Keywords provided by Halina Sienkiewicz-Jarosz, Institute of Psychiatry and Neurology, Warsaw:
ischemic stroke
smoking cessation
antismoking interventions
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes