StrokeNCT02769871
NICE: NeuroImaging in Cessation Education
A study testing Neuroimages of stroke and standardized smoking cessation counseling in people with Stroke and Smoking Cessation, run by Yale University.
Trial summary
The investigators aim to examine the effect on smoking cessation rate by showing stroke patients who are active smokers images of their strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Smoking Cessation
- What is being tested?
- Neuroimages of stroke and standardized smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Active smoker, as defined: at least 100 cigarettes in their entire life, must have smoked cigarette at least once in 4 days prior to onset of stroke
- Primary ischemic or hemorrhagic stroke identified on neuroimaging (MRI DWI/ADC or CT of brain)
- Onset of stroke symptoms within 30 days to time of recruitment
- Capacity to comprehend counseling data: Each participant will be given a cognitive screening test to assess the ability to comprehend and accurately answer the medical history questionnaire (MMSE). If the participant fails this test (score < 23), they will be excluded.
- Patients discharged home or short term rehab with expectation of returning home within the study period
Who cannot join
- Patients whose stroke deficits clinically prevent them from reasonably being physically able to continue to smoke, such as bilateral upper extremity paresis, tracheostomy, GCS ≥9
- Patients with sensory aphasia that impairs comprehension
- Subarachnoid hemorrhage
- Transient ischemic attack
- Other cause of cerebral ischemia or hemorrhage not defined as primary ischemic or hemorrhagic stroke (i.e. hemorrhagic metastases)
- Patients whose stroke symptoms started >30 days from time of enrollment
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- Patients discharged to acute rehab, long term acute care hospital or hospice who are unlikely to have access to cigarettes
- Patients unable to complete cognitive screening test for whom an appropriate proxy does not exist
- Patients who do not speak fluent English (given that the study largely revolves around oral education on smoking cessation, clear communication between participant and coordinator must be possible)
About this study
Official title: Effect of Showing Stroke Neuroimaging to Patients in Setting of Smoking Cessation Education on Smoking Cessation Rates in Patients With New Stroke.
The investigators aim to examine the effect on smoking cessation rate by showing stroke patients who are active smokers images of their strokes.
Read the detailed description
The investigators hypothesize that showing actual images of a patient's stroke to the participant on either brain CT or MRI will be a similarly easy to understand quantification of damage done to the participant's body. Given the link between smoking and stroke risk, the investigators believe that providing this imaging in addition to standard smoking cessation education may improve rates of smoking cessation after stroke. If this proves true, addition of a patient's neuroimaging to standard post-stroke smoking cessation education would be an easy method to improve smoking cessation rates in stroke patients, at minimal cost.
- Conditions
- Stroke, Smoking Cessation
- Being tested
- Neuroimages of stroke, standardized smoking cessation counseling
- Medical subject headings
- Stroke, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroimages of strokeBehavioural
Participants in the intervention group will be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, patients will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Patients will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging.
standardized smoking cessation counselingBehavioural
Standardized smoking cessation counseling will be provided at their initial interview. They will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants.
| Study group | Role | What they receive |
|---|---|---|
| Standardized smoking cessation counseling | Active comparator | Standardized smoking cessation counseling will be provided at the participant's initial interview. Participants will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants. Receives: Behavioral: standardized smoking cessation counseling |
| Neuroimages of stroke | Experimental | Participants in the intervention group will undergo standardized smoking cessation counseling (as offered to the active comparator group) and will also be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, participants will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Participants will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging. Receives: Behavioral: Neuroimages of stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
cessation of smoking measured by self-report collected during follow-up phone interviews.
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
Measured: 30 day follow-up visit
cessation of smoking measured by self-report collected during follow-up phone interviews.
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
Measured: 90 day follow-up visit
Secondary outcomes (2)
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
Measured: 30 day follow-up visit
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking.
Measured: 90 day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJan 2017
- Primary completionJul 2020
- Study completionJul 2020
Why it stopped: Loss of team members.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hardik Amin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769871
- Sponsor's protocol ID
- 1606017908
- Status last verified
- Jun 2019
- First submitted
- 10 May 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
Publications
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Showing Stroke Neuroimaging to Patients in Setting of Smoking Cessation Education on Smoking Cessation Rates in Patients With New Stroke.
- ClinicalTrials.gov ID
- NCT02769871
- Acronym / sponsor ID
- 1606017908
- Conditions
- Stroke, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of team members.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 12 May 2016 (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 investigators aim to examine the effect on smoking cessation rate by showing stroke patients who are active smokers images of their strokes.
Detailed description
The investigators hypothesize that showing actual images of a patient's stroke to the participant on either brain CT or MRI will be a similarly easy to understand quantification of damage done to the participant's body. Given the link between smoking and stroke risk, the investigators believe that providing this imaging in addition to standard smoking cessation education may improve rates of smoking cessation after stroke. If this proves true, addition of a patient's neuroimaging to standard post-stroke smoking cessation education would be an easy method to improve smoking cessation rates in stroke patients, at minimal cost.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized smoking cessation counseling | Active comparator | Behavioral: standardized smoking cessation counselingStandardized smoking cessation counseling will be provided at the participant's initial interview. Participants will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants. |
| Neuroimages of stroke | Experimental | Behavioral: Neuroimages of strokeParticipants in the intervention group will undergo standardized smoking cessation counseling (as offered to the active comparator group) and will also be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, participants will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Participants will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18
- Active smoker, as defined: at least 100 cigarettes in their entire life, must have smoked cigarette at least once in 4 days prior to onset of stroke
- Primary ischemic or hemorrhagic stroke identified on neuroimaging (MRI DWI/ADC or CT of brain)
- Onset of stroke symptoms within 30 days to time of recruitment
- Capacity to comprehend counseling data: Each participant will be given a cognitive screening test to assess the ability to comprehend and accurately answer the medical history questionnaire (MMSE). If the participant fails this test (score < 23), they will be excluded.
Key exclusion criteria (9 listed)
- Patients whose stroke deficits clinically prevent them from reasonably being physically able to continue to smoke, such as bilateral upper extremity paresis, tracheostomy, GCS ≥9
- Patients with sensory aphasia that impairs comprehension
- Subarachnoid hemorrhage
- Transient ischemic attack
- Other cause of cerebral ischemia or hemorrhage not defined as primary ischemic or hemorrhagic stroke (i.e. hemorrhagic metastases)
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 |
|---|---|---|
| Neuroimages of strokeParticipants in the intervention group will be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, patients will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Patients will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging. | Behavioural | Neuroimages of stroke |
| standardized smoking cessation counselingStandardized smoking cessation counseling will be provided at their initial interview. They will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants. | Behavioural | Standardized smoking cessation counseling |
Primary outcome
cessation of smoking measured by self-report collected during follow-up phone interviews.
Time frame: 30 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
cessation of smoking measured by self-report collected during follow-up phone interviews.
Time frame: 90 day follow-up visit
30 day and 90 day post-stroke phone interviews will be by a blinded APRN. During these interviews, patients will be asked their smoking status. If they are still smoking, they will be asked how much they are still smoking,
2 secondary outcomes
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Time frame: 30 day follow-up visit
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Time frame: 90 day follow-up visit
Results and safety
The study was stopped early (reason given: Loss of team members.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 34813082Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
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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.
Hardik Amin, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Neuroimages of stroke and standardized smoking cessation counseling in people with Stroke and Smoking Cessation, run by Yale University.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Loss of team members.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cessation of smoking measured by self-report collected during follow-up phone interviews. (time frame: 30 day follow-up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02769871, which also lists 1 linked publication.
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 12 Aug 2020.