NICE: NeuroImaging in Cessation Education

NCT ID: NCT02769871

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-07-31

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.

Conditions

Stroke; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Standardized smoking cessation counseling

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.

Group Type: ACTIVE_COMPARATOR

standardized smoking cessation counseling

Intervention Type: BEHAVIORAL

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.

Neuroimages of stroke

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.

Group Type: EXPERIMENTAL

Neuroimages of stroke

Intervention Type: BEHAVIORAL

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.

Interventions

Neuroimages of stroke

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

standardized smoking cessation counseling

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hardik Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

References

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.

Reference Type: DERIVED

PMID: 34813082 (View on PubMed)

Other Identifiers

1606017908

Identifier Type: -

Identifier Source: org_study_id