Clinical trial NCT01574001: Smoking Cessation Interventions in Stroke Patients
Official title: Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
smoking cessation
antismoking interventions
Lead sponsor: Institute of Psychiatry and Neurology, Warsaw
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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)

Primary outcomes:
measure: Smoking cessation rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Psychiatry and Neurology
Study officials:
affiliation: 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
name: Halina Sienkiewicz-Jarosz, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: