- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03194958
Aider les pauvres fumeurs à arrêter
Aider les pauvres à arrêter de fumer : lignes spécialisées pour arrêter de fumer et répondre aux besoins de base
Aperçu de l'étude
Statut
Les conditions
- Fumeur
- Sevrage tabagique
- Tabagisme
- Tabagisme
- Cesser de fumer
- Dépendance à la nicotine
- Dépendance au tabac
- Fumer, Tabac
- Trouble de l'utilisation de la nicotine
- Dépendance à la nicotine, cigarettes
- Fumer, Cigarette
- Dépendance à la nicotine Produit du tabac
- Le tabac; Utilisation, Réhabilitation
- Dépendance au tabac (tabac)
- Fumer, Pipe
Intervention / Traitement
Description détaillée
Les spécialistes de l'information 2-1-1 fourniront un service standard, puis demanderont à un nombre aléatoire d'appelants par jour s'ils seraient prêts à répondre à quelques questions sur la santé dans le cadre d'un nouveau service 2-1-1. Les appelants éligibles pour recevoir l'invitation à dépister l'éligibilité à l'étude seront : les résidents du Missouri, appelant pour eux-mêmes, anglophones et non en crise aiguë. On demandera ensuite aux fumeurs admissibles s'ils sont disposés à partager leurs coordonnées avec une équipe de recherche menant une étude pour aider les fumeurs à cesser de fumer. Les fumeurs qui acceptent de partager leurs coordonnées seront considérés comme "inscrits". Les opérateurs 2-1-1 formés enregistreront toutes les données de présélection du recrutement dans une base de données électronique sécurisée partagée avec le personnel de recherche. Le personnel de recherche tentera de joindre les fumeurs inscrits par téléphone d'ici le jour ouvrable suivant.
Alere, par l'intermédiaire de la Missouri Tobacco Quitline, fournira des services d'aide aux fumeurs dans toutes les conditions de l'étude. Les coordonnées et l'affectation des groupes d'étude pour les fumeurs seront fournies à Alere via un transfert de données sécurisé.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Missouri
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Saint Louis, Missouri, États-Unis, 63130
- Washington University in St. Louis
-
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- 18 ans et plus
- Résident du Missouri
- anglophone
- Pas en crise
- Fumer des cigarettes tous les jours de la semaine
- Planification d'arrêter de fumer dans les 30 prochains jours
- Être à l'aise pour recevoir des appels d'un expert en tabagisme et de l'équipe de projet
- Disposé à fournir les numéros de téléphone à joindre
Critère d'exclusion:
- Enceinte ou prévoyant de devenir enceinte dans les 3 prochains mois
- Allaite actuellement
- Assurance par l'employeur
- Actuellement inscrit à la ligne d'aide pour arrêter de fumer
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Ligne d'arrêt standard
Les participants recevront les services standard de la ligne d'assistance téléphonique du Missouri
|
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Expérimental: Ligne d'aide spécialisée
Les participants recevront une version améliorée des services standard de la ligne d'aide au sevrage.
|
Les fumeurs à très faible revenu se distinguent des autres fumeurs par des aspects importants qui ne sont pas toujours pris en compte par les services d'aide téléphonique standard.
L'équipe de recherche et le personnel d'Alere ont créé des protocoles personnalisés, des scripts, des invites et d'autres contenus pour maximiser la pertinence et l'acceptabilité de l'intervention pour les fumeurs à très faible revenu.
Les entraîneurs de l'unité de mise en œuvre de la recherche (RIU) qui fourniront les services de la ligne d'aide spécialisée ont reçu une formation du personnel de la ligne d'aide clinique, de l'équipe de recherche et du personnel 2-1-1 qui ont une vaste expérience avec la population cible.
Les domaines d'intérêt pour la formation et le contenu et le protocole distinctifs de la ligne d'aide spécialisée pour arrêter de fumer comprennent : la littératie en santé, le langage abstrait par rapport au concret, l'expérience vécue, les contraintes de ressources, l'orientation future, l'obtention de cigarettes, la situation de vie, l'accès au téléphone/à Internet.
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Expérimental: Ligne d'arrêt standard avec navigateur pour les besoins de base
Les participants reçoivent des services standard de ligne d'arrêt avec navigateur
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Les navigateurs : (1) identifieront et évalueront les besoins des fumeurs, y compris les raisons pour lesquelles ils ont appelé le 2-1-1 ; (2) générer conjointement des solutions pour répondre aux besoins ; (3) élaborer des plans pour mettre en œuvre les solutions, y compris ; (4) aider à hiérarchiser les besoins multiples ; (5) identifier les ressources communautaires qui pourraient aider à résoudre le problème; (6) déterminer l'admissibilité aux services; (7) aider les fumeurs à accéder aux ressources disponibles en fixant des rendez-vous et en fournissant des rappels de rendez-vous ; (8) préparer les fumeurs à interagir avec les agences de services et/ou à agir en leur nom ; (9) fournir un soutien instrumental tel que l'organisation du transport ; (10) interviennent activement pour résoudre les obstacles aux solutions aux besoins fondamentaux ; (11) superviser le suivi des actions de résolution de problèmes; et (12) examiner les progrès accomplis vers la résolution des besoins fondamentaux non satisfaits et adapter les solutions en conséquence.
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Expérimental: Ligne d'arrêt spécialisée avec navigateur pour les besoins fondamentaux
Les participants reçoivent des services améliorés de ligne d'arrêt avec le navigateur
|
Les fumeurs à très faible revenu se distinguent des autres fumeurs par des aspects importants qui ne sont pas toujours pris en compte par les services d'aide téléphonique standard.
L'équipe de recherche et le personnel d'Alere ont créé des protocoles personnalisés, des scripts, des invites et d'autres contenus pour maximiser la pertinence et l'acceptabilité de l'intervention pour les fumeurs à très faible revenu.
Les entraîneurs de l'unité de mise en œuvre de la recherche (RIU) qui fourniront les services de la ligne d'aide spécialisée ont reçu une formation du personnel de la ligne d'aide clinique, de l'équipe de recherche et du personnel 2-1-1 qui ont une vaste expérience avec la population cible.
Les domaines d'intérêt pour la formation et le contenu et le protocole distinctifs de la ligne d'aide spécialisée pour arrêter de fumer comprennent : la littératie en santé, le langage abstrait par rapport au concret, l'expérience vécue, les contraintes de ressources, l'orientation future, l'obtention de cigarettes, la situation de vie, l'accès au téléphone/à Internet.
Les navigateurs : (1) identifieront et évalueront les besoins des fumeurs, y compris les raisons pour lesquelles ils ont appelé le 2-1-1 ; (2) générer conjointement des solutions pour répondre aux besoins ; (3) élaborer des plans pour mettre en œuvre les solutions, y compris ; (4) aider à hiérarchiser les besoins multiples ; (5) identifier les ressources communautaires qui pourraient aider à résoudre le problème; (6) déterminer l'admissibilité aux services; (7) aider les fumeurs à accéder aux ressources disponibles en fixant des rendez-vous et en fournissant des rappels de rendez-vous ; (8) préparer les fumeurs à interagir avec les agences de services et/ou à agir en leur nom ; (9) fournir un soutien instrumental tel que l'organisation du transport ; (10) interviennent activement pour résoudre les obstacles aux solutions aux besoins fondamentaux ; (11) superviser le suivi des actions de résolution de problèmes; et (12) examiner les progrès accomplis vers la résolution des besoins fondamentaux non satisfaits et adapter les solutions en conséquence.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Abstinence 6 mois
Délai: 6 mois après le départ
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Rapporter l'abstinence à prévalence ponctuelle sur 7 jours mesurée à 6 mois après l'inclusion
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6 mois après le départ
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Abstinence 3 mois
Délai: 3 mois après le départ
|
Rapporter l'abstinence à prévalence ponctuelle sur 7 jours mesurée à 3 mois après l'inclusion
|
3 mois après le départ
|
Tentative d'arrêt de 24 heures
Délai: 6 mois après le départ
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Déclarer avoir arrêté de fumer pendant au moins 24 heures pendant l'intervention
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6 mois après le départ
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Matthew Kreuter, PhD, Washington University School of Medicine
Publications et liens utiles
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