NICE: NeuroImaging in Cessation Education
10 augustus 2020 bijgewerkt door: Yale University
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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
20
Fase
- Niet toepasbaar
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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.
|
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.
|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
cessation of smoking measured by self-report collected during follow-up phone interviews.
Tijdsspanne: 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,
|
30 day follow-up visit
|
|
cessation of smoking measured by self-report collected during follow-up phone interviews.
Tijdsspanne: 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,
|
90 day follow-up visit
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Tijdsspanne: 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,
|
30 day follow-up visit
|
|
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Tijdsspanne: 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.
|
90 day follow-up visit
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Hardik Amin, MD, Yale University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2017
Primaire voltooiing (Werkelijk)
1 juli 2020
Studie voltooiing (Werkelijk)
1 juli 2020
Studieregistratiedata
Eerst ingediend
10 mei 2016
Eerst ingediend dat voldeed aan de QC-criteria
10 mei 2016
Eerst geplaatst (Schatting)
12 mei 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 augustus 2020
Laatste update ingediend die voldeed aan QC-criteria
10 augustus 2020
Laatst geverifieerd
1 juni 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1606017908
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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