Smoking Cessation Interventions in Stroke Patients
Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
BACKGROUND: It is well known, that continued smoking after stroke increases the risk of death and stroke recurrence within a few years after the first stroke. Searching for more efficient methods of antismoking interventions is therefore justified.
OBJECTIVES: The primary objective of the present study is to compare the effectiveness of three anti-smoking interventions of different intensities.
DESIGN: Randomized, controlled trial.
METHODS: Study participants will be recruited among patients of neurological clinics of Institute of Psychiatry and Neurology, hospitalized because of their first in a lifetime ischemic stroke. All stroke patients will be screened regarding their smoking status. The subjects will be patients smoking cigarettes immediately before their first-ever stroke, able to understand the research protocol procedures and able to cooperate during the investigation.
Antismoking interventions will be based on the "5A's" method. Study participants will be randomized to one of three interventions differing in follow-up intensity.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Warsaw, Polen, 02-957
- Rekruttering
- Institute of Psychiatry and Neurology
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Ta kontakt med:
- Will
- Telefonnummer: +48224582548
- E-post: neurol1@ipin.edu.pl
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Hovedetterforsker:
- Halina Sienkiewicz-Jarosz, M.D., PhD
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Underetterforsker:
- Przemysław Bienkowski, M.D., Prof.
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Underetterforsker:
- Magdalena Restel, M.D.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients smoking immediately prior to stroke
- The first in the lifetime ischemic stroke
- Ability to understand the research protocol procedures and cooperation during the investigation
- Reported availability of and declaration to participate in follow-up
- Informed consent to participate in the study
Exclusion Criteria:
- Severe stroke
- Stroke onset more than 3 weeks before admission
- History of previous stroke with clinical symptoms
- Hemorrhagic stroke
- Diagnosis of dementia or presence of other neurological disease (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, Huntington's chorea, a previous subarachnoid haemorrhage, meningitis, cerebral trauma in an interview)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Antismoking intervention with minimal early follow-up
an intervention according to the "5A's" model with one follow-up visit within one week after discharge from the hospital; follow-up assessment will include two visits: 3 and 12 months after stroke
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Anti-smoking intervention in line with the "5A's" method (Ask, Advice, Assess, Assist, Arrange follow-up.
The intervention will be carried out 5-7 days after stroke, before the planned discharge from the hospital.
Seven days after discharge from a stroke unit a brief telephone/personal advice will be given aimed to motivate patients to quit smoking; follow-up assessment will include two visits: 3 and 12 months after stroke
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Aktiv komparator: Antismoking intervention with no early follow-up
an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke
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an anti-smoking intervention in line with the "5A's" method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke
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Eksperimentell: Antismoking intervention with intensive early follow-up
an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke
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an anti-smoking intervention in line with the "5A's" method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Smoking cessation rate
Tidsramme: 12 months
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12 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Halina Sienkiewicz-Jarosz, M.D., PhD, 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IPIN-01
- UMO-2011/01/B/NZ7/05402 (Annet stipend/finansieringsnummer: National Science Center, Poland)
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