NCT04045964已完成4 期
Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年10月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
研究概览
简要总结
The purpose of this study was to explore the potential for directly targeting smoking cessation, regardless of motivation level, in a subsample of neonatal intensive care unit (NICU) parents with the ultimate goal of reducing secondhand smoke (SHS) in their homes.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible mothers of any age or ethnic background must have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU (ensuring time for the intervention)
- •report that a household resident smokes at least 5 cigarettes per day, on average, within the 2 months preceding the screening visit
- •agree to attend intervention sessions
- •live within 50 miles of our center
- •and have access to a telephone
排除标准
- •Mothers were ineligible if they met criteria for severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- •were unable to read, write, and speak English
- •were unable or unwilling to provide signed consent for participation
- •and were unable or unwilling to meet study requirements for data collection and intervention purposes.
- •Within the month immediately preceding the screening visit, use of any form of tobacco or nicotine products other than cigarettes (e.g., e-cigarettes, chewing tobacco, etc.) on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
- •Current use of NRT or enrollment (or plans to enroll) in another smoking cessation program in the next 3 months
- •Uncontrolled hypertension (systolic blood pressure [SBP] greater than 180 or diastolic blood pressure [DBP] greater than 110)
- •History of severe cardiovascular (stroke, heart attack), kidney (e.g. chronic or acute kidney failure) or liver disease, or other unstable disease in the last 3 months
- •History of hypersensitivity or allergic reaction to NRT or similar chemical classes or any component of these formulations (including allergy to latex)
研究组 & 干预措施
Motivational advice and free NRT
Experimental
干预措施: nicotine replacement therapy (NRT) (Drug)
Motivational advice and free NRT
Experimental
干预措施: motivational advice (Behavioral)
Quitline referral
Active Comparator
干预措施: Quitline referral (Behavioral)
结局指标
主要结局
Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.
时间窗: From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)
Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.
时间窗: From time of randomization to follow-up visit #2 (generally completed within 2-3 months)
次要结局
- Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.(From time of randomization to follow-up visit #2 (generally completed within 2-3 months))
- Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)(baseline)
- Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.(From time of randomization to follow-up visit #2 (generally completed within 2-3 months))
- Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner(baseline)
- Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))
- Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant(Baseline)
- Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))
- Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts(at the time of follow-up visit #2 (about 1 month post-intervention))
研究者
Angela L Stotts
Professor and Vice Chair for Research (Department of Family & Community Medicine)
The University of Texas Health Science Center, Houston
研究点 (1)
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