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- Registre américain des essais cliniques
- Essai clinique NCT01574001
Smoking Cessation Interventions in Stroke Patients
Comparison of Smoking Cessation Interventions of Different Intensities in Patients With First Ever Ischemic Stroke.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Warsaw, Pologne, 02-957
- Recrutement
- Institute of Psychiatry and Neurology
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Contact:
- Will
- Numéro de téléphone: +48224582548
- E-mail: neurol1@ipin.edu.pl
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Chercheur principal:
- Halina Sienkiewicz-Jarosz, M.D., PhD
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Sous-enquêteur:
- Przemysław Bienkowski, M.D., Prof.
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Sous-enquêteur:
- Magdalena Restel, M.D.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Smoking cessation rate
Délai: 12 months
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12 months
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Halina Sienkiewicz-Jarosz, M.D., PhD, 1st Department of Neurology, Institute of Psychiatry and Neurology, 9 Sobieskiego Str., 02-957 Warsaw, Poland
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IPIN-01
- UMO-2011/01/B/NZ7/05402 (Autre subvention/numéro de financement: National Science Center, Poland)
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