Smoking Cessation Interventions in Stroke Patients

Institute of Psychiatry and Neurology, Warsaw

Status: Unknown

Conditions: Ischemic Stroke

Treatments: Behavioral: Antismoking intervention with minimal early follow-up; Behavioral: Antismoking intervention with intensive early follow-up; Behavioral: Antismoking intervention with no early follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT01574001

IPIN-01

UMO-2011/01/B/NZ7/05402 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Antismoking intervention with minimal early follow-up

Experimental group

Description:

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

Treatment:

Behavioral: Antismoking intervention with minimal early follow-up

Antismoking intervention with no early follow-up

Active Comparator group

Description:

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

Treatment:

Behavioral: Antismoking intervention with no early follow-up

Antismoking intervention with intensive early follow-up

Experimental group

Description:

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

Treatment:

Behavioral: Antismoking intervention with intensive early follow-up