Clinical trial NCT02769871: 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
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: cessation of smoking measured by self-report collected during follow-up phone interviews.
timeFrame: 30 day follow-up visit
measure: cessation of smoking measured by self-report collected during follow-up phone interviews.
timeFrame: 90 day follow-up visit
Secondary outcomes:
measure: number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
timeFrame: 30 day follow-up visit
measure: number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
timeFrame: 90 day follow-up visit
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Hardik Amin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.