Smoking Cessation Program in the Preadmission Clinic
Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates
Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Ontario
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Toronto、Ontario、カナダ、M5T2S8
- Toronto Western Hospital, Department of Aneshtesia
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Toronto、Ontario、カナダ
- Mount Sinai Hospital, Department of Anesthesia
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients who smoke more than 10 cigarettes per day for more than 1 year
- And had no period of smoking abstinence longer than 3 months in the past year.
- Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age
Exclusion Criteria:
- Patients unwilling or unable to give informed consent
- Patients who are pregnant and breast feeding
- Patients with any psychiatric disorder
- Patients who used nicotine replacement / bupropion within previous 3 months
- Cardiovascular disease within the past 6 months
- Any serious or unstable disease within the past 6 months
- Drug or alcohol abuse within the past year.
研究計画
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Smoking cessation group
Counselling, Pharmacotherapy and Smokers Help Line
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The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
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他の：Control group
Brief informatin about quitting and smokers help line
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Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
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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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pre-surgery counseling for quit smoking
時間枠：1 year after surgery
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In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:
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1 year after surgery
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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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perioperative complications
時間枠：3 months after surgery
|
Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date.
The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program).
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3 months after surgery
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協力者と研究者
協力者
捜査官
- 主任研究者：Frances Chung, FRCPC、University Health Network, Toronto
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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