NICE: NeuroImaging in Cessation Education
10. august 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cessation of smoking measured by self-report collected during follow-up phone interviews.
Tidsramme: 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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
number of cigarettes smoked per day measured by self-report collected during follow-up phone interviews.
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Hardik Amin, MD, Yale University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Faktiske)
1. juli 2020
Studieafslutning (Faktiske)
1. juli 2020
Datoer for studieregistrering
Først indsendt
10. maj 2016
Først indsendt, der opfyldte QC-kriterier
10. maj 2016
Først opslået (Skøn)
12. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2020
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1606017908
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