Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
1 de junho de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
314
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Doha, Catar
- Primary Health Corporation (PHC) pharmacies
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Doha, Catar
- Qatar Petroleum pharmacies
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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).
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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).
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Experimental: 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.
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Self-reported 7-day Point Prevalence Abstinence
Prazo: 3 months
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Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days
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3 months
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Self-reported 30 Day Smoking Abstinence
Prazo: 3 months
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Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days
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3 months
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Self-reported Continuous Abstinence at 3 Months
Prazo: 3 months
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Self-reported continuous abstinence defined as having smoked no cigarettes since quit day
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3 months
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Self-reported 7-day Point Prevalence Abstinence
Prazo: 6 months
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Defined as having smoked no cigarettes for the previous 7 days
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6 months
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Self-reported 30-day Point Prevalence Abstinence
Prazo: 6 months
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Defined as having smoked no cigarettes in the last 30 days
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6 months
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Self-reported Continuous Abstinence
Prazo: 6 months
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Defined as having smoked no cigarettes since quit day
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6 months
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Self-reported 7-day Point Prevalence Abstinence
Prazo: 12 months
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Defined as having smoked no cigarettes for the previous 7 days
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12 months
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Self-reported 30-day Point Prevalence Abstinence
Prazo: 12 months
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Defined as having smoked no cigarettes in the last 30 days
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12 months
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Self-reported Continuous Abstinence
Prazo: 12 months
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Defined as having smoked no cigarettes since quit day at 12 months
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12 months
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Objective Smoking Abstinence
Prazo: 12 months
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Smoking abstinence as objectively verified by the CO exhaled test at 12 months
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12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Health Related Quality of Life
Prazo: 6 month
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Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters
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6 month
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maguy S El Hajj, PharmD, Qatar University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- El Hajj MS, Kheir N, Al Mulla AM, Shami R, Fanous N, Mahfoud ZR. Effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: a randomized controlled trial. BMC Public Health. 2017 Feb 20;17(1):215. doi: 10.1186/s12889-017-4103-4.
- El Hajj MS, Kheir N, Al Mulla AM, Al-Badriyeh D, Al Kaddour A, Mahfoud ZR, Salehi M, Fanous N. Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial. Trials. 2015 Feb 26;16:65. doi: 10.1186/s13063-015-0570-z.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2013
Conclusão Primária (Real)
1 de dezembro de 2015
Conclusão do estudo (Real)
1 de junho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
20 de abril de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de abril de 2014
Primeira postagem (Estimativa)
25 de abril de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de janeiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2017
Última verificação
1 de junho de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- NPRP 4 - 716 - 3 - 203
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .