Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar

1 juin 2017 mis à jour par: Dr. Maguy El Hajj, Qatar University
Thirty seven percent of adult male population smoke cigarettes in Qatar. The Global Youth Tobacco Survey also stated that 13.4% of male school students aged 13 to 15 years in Qatar smoke cigarettes. Smoking cessation is a key to reducing smoking related diseases and deaths. Health care providers are in an ideal position to encourage smoking cessation. Pharmacists are the most accessible health care providers and are uniquely situated to initiate behavior change among patients. Many western studies have shown that pharmacists can be successful in helping patients quit smoking. Studies demonstrating the effectiveness of pharmacist delivered smoking cessation programs are lacking in Qatar. This proposal aims to test the effect of a structured smoking cessation program delivered by trained ambulatory pharmacists in Qatar. A prospective, randomized, controlled trial will be conducted at 8 ambulatory pharmacies in Qatar. Participants will be randomly assigned to receive a 4-session face-to-face structured patient-specific smoking cessation program conducted by the pharmacist or 5 to 10 minutes of unstructured brief smoking cessation advice given by the pharmacist. Both groups will be offered nicotine therapy if feasible. The primary outcome of smoking cessation will be confirmed by exhaled carbon monoxide test at 12 months. If proven to be effective, this smoking cessation program will be considered as a model that Qatar and the region can apply to decrease smoking burden.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

314

Phase

  • N'est pas applicable

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

  • Qatar
      • Doha, Qatar
        • Primary Health Corporation (PHC) pharmacies
      • Doha, Qatar
        • Qatar Petroleum pharmacies

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

Eligible participants are:

  • patients aged 18 years and older who currently smoke one or more cigarettes daily for 7 days, are motivated to quit i.e.: in the preparation stage of the stage-of-change model, able to communicate in Arabic or English and are willing and capable of attending the scheduled sessions at the study pharmacies.

Exclusion criteria are:

  • use of other nicotine or tobacco products
  • current use or use in the last 30 days of quit smoking aids or medications
  • plan to leave Qatar in the next 12 months
  • presence of any major medical condition that would prevent use of the nicotine replacement therapy including hypersensitivity to the products, history of or recent myocardial infarction, life-threatening arrhythmias, severe or worsening angina, uncontrolled hypertension and temporomandibular joint disease (in case of nicotine gum)
  • pregnancy
  • psychiatric illness or other debilitating condition that would interfere with participation in the study.

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: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control arm
Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
Autre: Control arm (i.e: regular care)
Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
Expérimental: Intervention arm
Participants assigned to the intervention arm will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks in addition to nicotine replacement therapy. The sessions will be set at a date and time that is convenient for both the pharmacist and the participant. The pharmacist will deliver the program at a time different from his or her pharmacy duty regular time.
Comportemental: Pharmacist delivered smoking cessation program

The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies.

To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability.

• If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems

Autres noms:
  • Participants will participate in a face-to-face 4-session program at the pharmacy delivered by the study pharmacist at 2-4-week intervals over 8 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Self-reported 7-day Point Prevalence Abstinence
Délai: 3 months
Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
3 months
Self-reported 30 Day Smoking Abstinence
Délai: 3 months
Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
3 months
Self-reported Continuous Abstinence at 3 Months
Délai: 3 months
Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
3 months
Self-reported 7-day Point Prevalence Abstinence
Délai: 6 months
Defined as having smoked no cigarettes for the previous 7 days
6 months
Self-reported 30-day Point Prevalence Abstinence
Délai: 6 months
Defined as having smoked no cigarettes in the last 30 days
6 months
Self-reported Continuous Abstinence
Délai: 6 months
Defined as having smoked no cigarettes since quit day
6 months
Self-reported 7-day Point Prevalence Abstinence
Délai: 12 months
Defined as having smoked no cigarettes for the previous 7 days
12 months
Self-reported 30-day Point Prevalence Abstinence
Délai: 12 months
Defined as having smoked no cigarettes in the last 30 days
12 months
Self-reported Continuous Abstinence
Délai: 12 months
Defined as having smoked no cigarettes since quit day at 12 months
12 months
Objective Smoking Abstinence
Délai: 12 months
Smoking abstinence as objectively verified by the CO exhaled test at 12 months
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Health Related Quality of Life
Délai: 6 month
Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
6 month

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Qatar University

Collaborateurs

Hamad Medical Corporation

Les enquêteurs

  • Chercheur principal: Maguy S El Hajj, PharmD, Qatar University

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.

Publications générales

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 février 2013

Achèvement primaire (Réel)

1 décembre 2015

Achèvement de l'étude (Réel)

1 juin 2016

Dates d'inscription aux études

Première soumission

20 avril 2014

Première soumission répondant aux critères de contrôle qualité

24 avril 2014

Première publication (Estimation)

25 avril 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 janvier 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2017

Dernière vérification

1 juin 2017

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • NPRP 4 - 716 - 3 - 203

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 .

S'abonner