Smoking Cessation Interventions in Stroke Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Ischemic Stroke
• Intervention / Treatment: Behavioral: Antismoking intervention with minimal early follow-up; Behavioral: Antismoking intervention with no early follow-up; Behavioral: Antismoking intervention with intensive early follow-up

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-957
    • Recruiting
    • Institute of Psychiatry and Neurology
    • Contact: Will; Phone Number: +48224582548; Email: 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking cessation rate	12 months

Collaborators and Investigators

• Sponsor: Institute of Psychiatry and Neurology, Warsaw
• Investigators: Principal Investigator: Halina Sienkiewicz-Jarosz, M.D., PhD, 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: April 1, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): May 15, 2013
• Last Update Submitted That Met QC Criteria: May 14, 2013
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: smoking cessation; ischemic stroke; antismoking interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: IPIN-01; UMO-2011/01/B/NZ7/05402 (Other Grant/Funding Number: National Science Center, Poland)