Back to resultsNICE: NeuroImaging in Cessation Education
Primary Purpose
Stroke, Smoking Cessation
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuroimages of stroke
standardized smoking cessation counseling
Sponsored by
About this trial
This is an interventional prevention trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standardized smoking cessation counseling
Neuroimages of stroke
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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,
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,
Secondary Outcome Measures
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,
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02769871
Brief Title
NICE: NeuroImaging in Cessation Education
Official Title
Effect of Showing Stroke Neuroimaging to Patients in Setting of Smoking Cessation Education on Smoking Cessation Rates in Patients With New Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Loss of team members.
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Smoking Cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standardized smoking cessation counseling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neuroimages of stroke
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neuroimages of stroke
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standardized smoking cessation counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
cessation of smoking measured by self-report collected during follow-up phone interviews.
Description
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,
Time Frame
30 day follow-up visit
Title
cessation of smoking measured by self-report collected during follow-up phone interviews.
Description
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,
Time Frame
90 day follow-up visit
Secondary Outcome Measure Information:
Title
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Description
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,
Time Frame
30 day follow-up visit
Title
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Description
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.
Time Frame
90 day follow-up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hardik Amin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813082
Citation
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.
Results Reference
derived
Learn more about this trial
NICE: NeuroImaging in Cessation Education
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