Évaluation d'un programme de télémédecine pour l'abandon du tabac dans les pratiques de soins primaires en milieu rural
4 octobre 2012 mis à jour par: Kimber Richter, PhD, MPH, MA
Télémédecine pour l'abandon du tabac dans les soins primaires en milieu rural
Les personnes qui fument des cigarettes et vivent dans des régions rurales n'ont peut-être pas accès à une grande variété de ressources pour les aider à arrêter de fumer.
Cette étude évaluera deux programmes de renoncement au tabac - un programme de télémédecine sur Internet et un programme de ligne téléphonique d'aide au renoncement - parmi les résidents ruraux.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Les personnes qui vivent dans les zones rurales sont plus susceptibles de fumer des cigarettes que les personnes qui vivent dans les zones urbaines et suburbaines. Cependant, de nombreuses ressources et programmes de sevrage tabagique peuvent ne pas être disponibles pour les résidents des régions rurales. Il a été prouvé que les lignes téléphoniques sans frais pour arrêter de fumer aident les gens à arrêter de fumer et sont accessibles à presque toutes les personnes vivant aux États-Unis, mais seulement 1 à 5 % des fumeurs les utilisent réellement. Une autre option pour aider les gens à arrêter de fumer peut impliquer que les médecins offrent des programmes de sevrage tabagique dans leurs cabinets ou cliniques ; cependant, la plupart des cabinets de médecins n'ont pas les ressources nécessaires pour fournir ce type de service. La télémédecine fournit des informations médicales par téléphone ou par Internet en utilisant diverses technologies, notamment des webcams ou des équipements de vidéoconférence. Il a été utilisé avec succès pour fournir des soins psychiatriques et des conseils en matière de toxicomanie, mais aucune étude n'a examiné l'efficacité d'un programme de désaccoutumance au tabac par télémédecine. Le but de cette étude est de comparer l'efficacité d'un programme de désaccoutumance au tabac par télémédecine qui se déroule dans un cabinet médical par rapport à l'efficacité d'un programme de désaccoutumance au tabac par téléphone traditionnel chez les fumeurs ruraux.
L'étude sera menée dans 25 cabinets de médecins ruraux du Kansas. Les participants seront assignés au hasard pour participer à un programme de ligne téléphonique d'aide au sevrage ou à un programme de télémédecine. Les participants au programme de ligne téléphonique d'aide au renoncement recevront quatre séances de conseils téléphoniques de la part de conseillers en désaccoutumance au tabac sur une période de 8 semaines. Les participants au programme de télémédecine recevront quatre séances de conseils en télémédecine dispensées par des conseillers en désaccoutumance au tabac sur une période de 8 semaines, qui seront dispensées via des webcams bidirectionnelles sur des ordinateurs dans les cabinets de médecins. Tous les participants recevront des documents éducatifs et des plans de renoncement personnalisés, y compris des informations sur les médicaments de sevrage tabagique. Au départ et aux mois 3, 6 et 12, tous les participants prendront part à des entretiens téléphoniques avec les chercheurs de l'étude pour évaluer les habitudes tabagiques. Au départ et au mois 12, les participants enverront un échantillon de salive aux chercheurs afin de déterminer le niveau de nicotine dans le corps.
Type d'étude
Interventionnel
Inscription (Réel)
566
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University of Kansas Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Critère d'intégration:
- Fume des cigarettes tous les jours
- Fume cinq cigarettes ou plus par jour
- A fumé des cigarettes pendant au moins 1 an avant l'entrée à l'étude
- A une adresse personnelle et un numéro de téléphone
- Disposé à participer aux évaluations téléphoniques
- Disposé à être affecté à l'un des deux programmes d'études
Critère d'exclusion:
- Enceinte ou allaitante
- Un autre membre du ménage est inscrit à l'étude
- Quitter la zone de résidence dans les 14 mois suivant l'entrée aux études
- Le fournisseur de soins primaires ne participe pas à l'étude
- Utilisation d'autres formes de produits du tabac (par exemple, cigares, broche, tabac à priser) en plus des cigarettes
- Utilisation d'un médicament pour arrêter de fumer
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 1
Les participants prendront part à un programme de télémédecine pour cesser de fumer.
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Les participants recevront quatre séances de télémédecine pour cesser de fumer sur une période de 8 semaines.
Les séances de télémédecine seront dispensées par des webcams bidirectionnelles montées sur des ordinateurs de bureau dans les cabinets des médecins.
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Comparateur actif: 2
Les participants prendront part à un programme téléphonique d'aide à l'abandon du tabac.
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Les participants recevront quatre séances de conseils sur l'abandon du tabac dispensées par téléphone à leur domicile sur une période de 8 semaines.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Abstinence à prévalence ponctuelle sur 7 jours
Délai: Mesuré aux mois 3, 6 et 12
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Mesuré aux mois 3, 6 et 12
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Abstinence prolongée
Délai: Mesuré aux mois 3, 6 et 12
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Mesuré aux mois 3, 6 et 12
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kimber P. Richter, PhD, MPH, MA, University of Kansas
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2009
Achèvement primaire (Réel)
1 avril 2012
Achèvement de l'étude (Réel)
1 avril 2012
Dates d'inscription aux études
Première soumission
12 février 2009
Première soumission répondant aux critères de contrôle qualité
12 février 2009
Première publication (Estimation)
13 février 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
5 octobre 2012
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 octobre 2012
Dernière vérification
1 octobre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 625
- R01HL087643-01A2 (Subvention/contrat des NIH des États-Unis)
- HL087643-01A2
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Programme d'abandon du tabac par télémédecine
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