Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Doha、卡塔尔
- Primary Health Corporation (PHC) pharmacies
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Doha、卡塔尔
- Qatar Petroleum pharmacies
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器: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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实验性的: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
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-reported 7-day Point Prevalence Abstinence
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Related Quality of Life
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Maguy S El Hajj, PharmD、Qatar University
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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