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Smoking Cessation Interventions in Stroke Patients

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Antismoking intervention with no early follow-up
Antismoking intervention with minimal early follow-up
Antismoking intervention with intensive early follow-up
Sponsored by
Institute of Psychiatry and Neurology, Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring ischemic stroke, smoking cessation, antismoking interventions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Institute of Psychiatry and NeurologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Antismoking intervention with minimal early follow-up

Antismoking intervention with no early follow-up

Antismoking intervention with intensive early follow-up

Arm 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

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

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

Outcomes

Primary Outcome Measures

Smoking cessation rate

Secondary Outcome Measures

Full Information

First Posted
April 1, 2012
Last Updated
May 14, 2013
Sponsor
Institute of Psychiatry and Neurology, Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01574001
Brief Title
Smoking Cessation Interventions in Stroke Patients
Official Title
Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry and Neurology, Warsaw

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, smoking cessation, antismoking interventions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antismoking intervention with minimal early follow-up
Arm Type
Experimental
Arm 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
Arm Title
Antismoking intervention with no early follow-up
Arm Type
Active Comparator
Arm 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
Arm Title
Antismoking intervention with intensive early follow-up
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Antismoking intervention with no early follow-up
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Antismoking intervention with minimal early follow-up
Intervention Description
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
Intervention Name(s)
Antismoking intervention with intensive early follow-up
Intervention 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
Primary Outcome Measure Information:
Title
Smoking cessation rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halina Sienkiewicz-Jarosz, M.D., PhD
Phone
+48224582548
Email
jarosz@ipin.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halina Sienkiewicz-Jarosz, M.D., PhD
Organizational Affiliation
1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Psychiatry and Neurology
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Will
Phone
+48224582548
Email
neurol1@ipin.edu.pl
First Name & Middle Initial & Last Name & Degree
Halina Sienkiewicz-Jarosz, M.D., PhD
First Name & Middle Initial & Last Name & Degree
Przemysław Bienkowski, M.D., Prof.
First Name & Middle Initial & Last Name & Degree
Magdalena Restel, M.D.

12. IPD Sharing Statement

Learn more about this trial

Smoking Cessation Interventions in Stroke Patients

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