Assessing the Effectiveness of a Pharmacist-delivered Smoking Cessation Program in the State of Qatar
2017年6月1日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
314
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Doha、カタール
- Primary Health Corporation (PHC) pharmacies
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Doha、カタール
- Qatar Petroleum pharmacies
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-reported 7-day Point Prevalence Abstinence
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health Related Quality of Life
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Maguy S El Hajj, PharmD、Qatar University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年2月1日
一次修了 (実際)
2015年12月1日
研究の完了 (実際)
2016年6月1日
試験登録日
最初に提出
2014年4月20日
QC基準を満たした最初の提出物
2014年4月24日
最初の投稿 (見積もり)
2014年4月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年1月2日
QC基準を満たした最後の更新が送信されました
2017年6月1日
最終確認日
2017年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。