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临床试验/NCT02123329
NCT02123329已完成不适用

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

Qatar University2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2013年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
314
试验地点
2
主要终点
Self-reported 30 Day Smoking Abstinence

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Control arm

Active Comparator

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).

干预措施: Control arm (i.e: regular care) (Other)

Intervention arm

Experimental

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.

干预措施: Pharmacist delivered smoking cessation program (Behavioral)

结局指标

主要结局

Self-reported 30 Day Smoking Abstinence

时间窗: 3 months

Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days

Self-reported Continuous Abstinence at 3 Months

时间窗: 3 months

Self-reported continuous abstinence defined as having smoked no cigarettes since quit day

Objective Smoking Abstinence

时间窗: 12 months

Smoking abstinence as objectively verified by the CO exhaled test at 12 months

Self-reported 7-day Point Prevalence Abstinence

时间窗: 12 months

Defined as having smoked no cigarettes for the previous 7 days

Self-reported 30-day Point Prevalence Abstinence

时间窗: 12 months

Defined as having smoked no cigarettes in the last 30 days

Self-reported Continuous Abstinence

时间窗: 12 months

Defined as having smoked no cigarettes since quit day at 12 months

Self-reported 7-day Point Prevalence Abstinence

时间窗: 3 months

Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days

Self-reported 7-day Point Prevalence Abstinence

时间窗: 6 months

Defined as having smoked no cigarettes for the previous 7 days

Self-reported 30-day Point Prevalence Abstinence

时间窗: 6 months

Defined as having smoked no cigarettes in the last 30 days

Self-reported Continuous Abstinence

时间窗: 6 months

Defined as having smoked no cigarettes since quit day

次要结局

  • Health Related Quality of Life(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Maguy El Hajj

Assistant Professor and Chair/ Clinical Pharmacy and Practice Section

Qatar University

研究点 (2)

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