Smoking Cessation Interventions in Stroke Patients
Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
2 other identifiers
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 15, 2013
April 1, 2012
1.7 years
April 1, 2012
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking cessation rate
12 months
Study Arms (3)
Antismoking intervention with minimal early follow-up
EXPERIMENTALan 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 no early follow-up
ACTIVE COMPARATORan 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
EXPERIMENTALan 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
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Psychiatry and Neurology
Warsaw, 02-957, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halina Sienkiewicz-Jarosz, M.D., PhD
1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2012
First Posted
April 10, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
May 15, 2013
Record last verified: 2012-04