Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98104
- Wisconsin Tobacco Quit Line (service provided by Free & Clear, Inc.)
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Wisconsin
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Madison、Wisconsin、アメリカ、53711
- University of Wisconsin Center for Tobacco Research and Intervention
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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
The only people eligible for this study are Wisconsin residents who contact the Wisconsin Tobacco Quit Line for smoking cessation services.
Inclusion Criteria:
- Callers will be eligible to participate in the study if they are English speaking; are 18 years of age or older; smoke a minimum of 10 cigarettes per day; are interested in quitting and are willing to set a quit date; willing and able to use nicotine patch and nicotine gum; agree to receive four follow-up counseling calls from Free & Clear (the quitline vendor for the State of Wisconsin); provide verbal informed consent; and provide contact information and agree to take four study follow-up calls from staff at the University of Wisconsin Center for Tobacco Research and Intervention.
Exclusion Criteria:
- Callers will be excluded if they are under the age of 18; are pregnant or breastfeeding; exclusively use other forms of tobacco (e.g., smokeless tobacco); are unwilling or unable to use study NRT medications; are currently using a cessation medication (NRT, bupropion, varenicline); or have medical exclusions as per FDA-approved product labeling.
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：階乗代入
- マスキング：独身
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：2 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day |
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アクティブコンパレータ：2 Weeks of Nicotine Patch Only plus CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
他の名前：
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アクティブコンパレータ：2 Wks Nicotine Patch+Nic Gum, No CMAC
Participants in this randomization arm received 2 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
他の名前：
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アクティブコンパレータ：2 Wks Nicotine Patch+Nic Gum plus CMAC
Participants in this randomization arm received 2 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 2 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 2 weeks 2 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 2 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
他の名前：
If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
他の名前：
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アクティブコンパレータ：6 Weeks of Nicotine Patch Only, No CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day |
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アクティブコンパレータ：6 Weeks of Nicotine Patch Only plus CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and standard cessation counseling plus Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
他の名前：
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アクティブコンパレータ：6 Wks Nicotine Patch+Nic Gum, No CMAC
Participants in this randomization arm received 6 weeks of nicotine patch plus nicotine gum and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
他の名前：
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アクティブコンパレータ：6 Wks Nicotine Patch+Nic Gum plus CMAC
Participants in this randomization arm received 6 weeks of nicotine patch and nicotine gum plus standard cessation counseling and Cognitive Medication Adherence Counseling 6 Weeks of Nicotine patch dosed as follows: If > 10 cigs/day: one 21 mg nicotine patch per day for 6 weeks If < or = 10 cigs/day: one 14 mg nicotine patch per day for 6 weeks 6 Weeks of Nicotine gum dosed as follows: If < 25 cigs/day, 2 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum for 6 weeks, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. |
If > 10 cigs/day: one 21 mg nicotine patch per day If < or = 10 cigs/day: one 14 mg nicotine patch per day
CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls.
The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
他の名前：
If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
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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7-Day Point Prevalence Abstinence From Smoking by Intervention
時間枠：26 weeks after the target quit smoking date
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Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
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26 weeks after the target quit smoking date
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7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group
時間枠：26 weeks after the target quit smoking date
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Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day.
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26 weeks after the target quit smoking date
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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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Incremental Cost-Effectiveness Ratio for 7-Day Point Prevalence Abstinence From Smoking at 26 Weeks Post-Quit by Nicotine Replacement Therapy (NRT) Group
時間枠：26 weeks after the target quit smoking date
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For cost analyses, we computed the costs of intervention per caller, the cost per quit based on the 6-month ITT 7-day PPA, and the incremental cost-effectiveness ratio (ICER.
Intervention costs included direct costs associated with registration, provision of NRT and counseling (standard and MAC), and mailing of a quit guide (all participants) and a MAC information sheet (MAC participants only).
Facility space, supplies, and physician supervision time were included in the call costs; research-related costs were excluded.
ICER ratio is a measure of the added cost per added quit for two treatments.
ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; e.g., the ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384)
= $357.
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26 weeks after the target quit smoking date
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協力者と研究者
協力者
捜査官
- 主任研究者：Stevens S Smith, PhD、University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- スタディディレクター：Paula A Keller, MPH、University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
出版物と役立つリンク
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- H2009-0074
- 1RC1CA144382-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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