Smoking Cessation Interventions in Stroke Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Behavioral: Antismoking intervention with no early follow-up
* Behavioral: Antismoking intervention with minimal early follow-up
* Behavioral: Antismoking intervention with intensive early follow-up


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antismoking intervention with minimal early follow-up<br>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<br>* 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<br>|
| Active Comparator: Antismoking intervention with no early follow-up<br>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<br>* 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<br>|
| Experimental: Antismoking intervention with intensive early follow-up<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation rate |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, smoking cessation, antismoking interventions