Ischemic StrokeNCT01574001
Smoking Cessation Interventions in Stroke Patients
A study testing Antismoking intervention with no early follow-up, Antismoking intervention with minimal early follow-up and Antismoking intervention with intensive early follow-up in people with Ischemic Stroke, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Antismoking intervention with no early follow-up, Antismoking intervention with minimal early follow-up and Antismoking intervention with intensive early follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Institute of Psychiatry and Neurology
Warsaw, 02-957
Will, +48224582548, neurol1@ipin.edu.pl
Halina Sienkiewicz-Jarosz, M.D., PhD
About this study
Official title: 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.
Read the 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
- Being tested
- Antismoking intervention with no early follow-up, Antismoking intervention with minimal early follow-up, Antismoking intervention with intensive early follow-up
- Keywords
- ischemic stroke, smoking cessation, antismoking interventions
- Medical subject headings
- Ischemic Stroke, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antismoking intervention with no early follow-upBehavioural
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-upBehavioural
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-upBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Antismoking intervention with minimal early follow-up | Experimental | 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 Receives: Behavioral: Antismoking intervention with minimal early follow-up |
| Antismoking intervention with no early follow-up | Active comparator | 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 Receives: Behavioral: Antismoking intervention with no early follow-up |
| Antismoking intervention with intensive early follow-up | Experimental | 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 Receives: Behavioral: Antismoking intervention with intensive early follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry and Neurology, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halina Sienkiewicz-Jarosz, Institute of Psychiatry and Neurology, Warsaw
- Investigators
- Halina Sienkiewicz-Jarosz, M.D., PhD, Principal investigator, 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574001
- Sponsor's protocol ID
- IPIN-01
- Other IDs
- UMO-2011/01/B/NZ7/05402
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2012
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT01574001
- Acronym / sponsor ID
- IPIN-01
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, smoking cessation, antismoking interventions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Institute of Psychiatry and Neurology, WarsawUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antismoking intervention with minimal early follow-up | Experimental | Behavioral: Antismoking intervention with minimal early follow-upan 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 comparator | Behavioral: Antismoking intervention with no early follow-upan 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 | Experimental | Behavioral: Antismoking intervention with intensive early follow-upan 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antismoking intervention with no early follow-upan 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 | Behavioural | Antismoking intervention with no early follow-up |
| Antismoking intervention with minimal early follow-upAnti-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 | Behavioural | Antismoking intervention with minimal early follow-up |
| Antismoking intervention with intensive early follow-upan 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 | Behavioural | Antismoking intervention with intensive early follow-up |
Primary outcome
Smoking cessation rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
Related trials for Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halina Sienkiewicz-Jarosz, M.D., PhD principal investigator
1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antismoking intervention with no early follow-up, Antismoking intervention with minimal early follow-up and Antismoking intervention with intensive early follow-up in people with Ischemic Stroke, run by Institute of Psychiatry and Neurology, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halina Sienkiewicz-Jarosz, M.D., PhD (+48224582548, jarosz@ipin.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.