Smoking Cessation Interventions in Stroke Patients

NCT ID: NCT01574001

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Antismoking intervention with minimal early follow-up

Intervention Type: BEHAVIORAL

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 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

Group Type: ACTIVE_COMPARATOR

Antismoking intervention with no early follow-up

Intervention Type: BEHAVIORAL

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 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

Group Type: EXPERIMENTAL

Antismoking intervention with intensive early follow-up

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Psychiatry and Neurology, Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Halina Sienkiewicz-Jarosz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Halina Sienkiewicz-Jarosz, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland

Locations

Institute of Psychiatry and Neurology

Warsaw, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Halina Sienkiewicz-Jarosz, M.D., PhD

Role: CONTACT

jarosz@ipin.edu.pl

+48224582548

Facility Contacts

Will

Role: primary

neurol1@ipin.edu.pl

+48224582548

Other Identifiers

UMO-2011/01/B/NZ7/05402

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IPIN-01

Identifier Type: -

Identifier Source: org_study_id