Smoking Cessation Interventions in Stroke Patients

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01574001
• Other study ID #: IPIN-01
• Secondary ID: UMO-2011/01/B/NZ
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2012
• Last updated: May 14, 2013
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2012
• Source: Institute of Psychiatry and Neurology, Warsaw
• Contact: Halina Sienkiewicz-Jarosz, M.D., PhD
• Phone: +48224582548
• Email: jarosz[@]ipin.edu.pl
• Is FDA regulated: No
• Health authority: Poland: National Science Center
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Poland	Institute of Psychiatry and Neurology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychiatry and Neurology, Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation rate		12 months	No