Smoking Cessation Interventions in Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Antismoking intervention with no early follow-up Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Antismoking intervention with no early follow-up
    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
  • Antismoking intervention with minimal early follow-up Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Antismoking intervention with minimal early follow-up
    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
  • Antismoking intervention with intensive early follow-up Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Antismoking intervention with intensive early follow-up
    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

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Smoking cessation rate 12 months No

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