Striving to Quit: First Breath (STQ FB)
Striving to Quit: First Breath Tobacco Cessation Research
調査の概要
状態
詳細な説明
Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of prenatal and postnatal smoking abstinence. Participants will be BadgerCare Plus members who are recruited into the First Breath program while pregnant.
Aim 2: To determine the extent to which treatment incentives, versus attendance incentives, increase rates of engagement in First Breath smoking cessation intervention when offered to pregnant and postpartum BadgerCare Plus members.
Aim 3: To determine the cost-effectiveness and reach of the First Breath intervention delivered to pregnant and postpartum smokers when it is paired with treatment incentives and when paired with only attendance incentives.
Aim 4: To determine if the First Breath intervention with treatment incentives, in comparison to that intervention with only attendance incentives, produces significantly greater benefits in pregnant and postpartum women with regards to nonsmoking health outcomes: i.e., reduced depression, increased levels of breast feeding, and greater perceived support.
Aim 5: To identify moderating and mediating effects of treatment incentives when offered in the context of the First Breath intervention delivered to pregnant and postpartum women.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53713
- Wisconsin Women's Health Foundation
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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:
- pregnant women
- enrollment in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- resides in study area
- member of participating Medicaid HMOs
- not involved in any other stop smoking research studies
- 18 or older
- English speaking
- smoked daily (at least one cigarette each day for at least one week) at some time within the last 6 months
- willingness to quit smoking, cut down, or stay quit
- willing to complete study visits and phone calls
- willing to provide updates in contact information
Exclusion Criteria:
- not enrolled in Wisconsin Medicaid (BadgerCare Plus or Medicaid SSI)
- not enrolled in study area
- not a member of participating Medicaid HMOs
- not pregnant or enrolled in First Breath
- less than 18 years of age
- non-English speaking
- does not smoke daily (at least one cigarette each day for at least one week) at least some time within the last 6 months
- not willing to complete study procedures and assessments or provide updated contact information
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：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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実験的：Treatment incentives
Incentives for biochemical verification visits, treatment engagement, and abstinence
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Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
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アクティブコンパレータ：Attendance incentive
Incentives for only attending the biochemical verification visits
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Attendance Incentives - incentives for only attending the biochemical verification visits
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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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Abstinence from smoking
時間枠：Measured 6 months after births at follow-up assessment
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The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)
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Measured 6 months after births at follow-up assessment
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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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Engagement in treatment
時間枠：Measured 12 months after birth at follow-up assessment
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The primary analyses will compare number of calls and visits completed.
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Measured 12 months after birth at follow-up assessment
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Cost-effectiveness
時間枠：Measured 12 months after birth
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The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.
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Measured 12 months after birth
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協力者と研究者
捜査官
- 主任研究者：Timothy B. Baker, PhD、University of Wisconsin, Madison
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 (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
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。
Incentives for abstinence and treatment engagementの臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了