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临床试验/NCT02695225
NCT02695225已完成不适用

Tobacco Cessation Interventions With Ohio Appalachian Smokers

Ohio State University0 个研究点目标入组 707 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
707
主要终点
Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml

研究概览

简要总结

Tobacco use remains a significant public health problem and is increasingly prevalent among vulnerable groups. Appalachians have a high prevalence of tobacco use and are at increased risk for tobacco-attributable diseases. The efficacy of a scientifically valid tobacco cessation treatment delivered to Appalachian smokers remains untested. Also, little is known about the association of social-contextual factors that may modify or mediate the success of an intervention. These factors may be of particular relevance among disadvantaged smokers. Geographical patterns of tobacco exposure may also influence one's ability to quit, especially in pro- tobacco regions like Appalachia. The purposes of this application are to: 1) evaluate the efficacy of a lay-led (LL) intervention in promoting long term abstinence from tobacco; and 2) examine the association between 12 month abstinence and selected individual, interpersonal, organizational, neighborhood and community, and societal factors among adult Appalachian tobacco users exposed to a tobacco cessation intervention. A third aim is exploratory and includes the characterization of activity patterns using space-time measures among adult Appalachian tobacco users exposed to a tobacco cessation intervention. Using a group randomized trial design, 707 Appalachian residents from 6 intervention and 6 control counties will be randomly assigned by county to receive the LL intervention or a control condition which includes proactive telephone counseling via the Ohio Quit Line. LL group participants will receive face-to-face counseling, supervised by a county health department nurse, and delivered by a trained lay educator. A county Extension agent will assist with recruitment and retention efforts in this project. Social-contextual factors will be assessed at a baseline interview administered to all participants. Space-time activity geographical patterns of pro- and anti-tobacco exposures, or features, will be described among selected participants in four counties during weeks 1, 6 and 12 of treatment. At end of treatment and 6 and 12 months, LL and control group participants will be reassessed for tobacco use via self-report and cotinine-validation. Secondary analyses will explore differential trends over time between the two arms of the study. In a subset of the sample, pro- and anti-tobacco exposures will be estimated during weeks 1, 6 and 12 of treatment.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • 18 years and older
  • Current self-reported use of tobacco on a daily basis
  • Resident of one of the 12 participating counties
  • Absence of clinical condition that contraindicates use of over-the-counter NRT, including: severe arrhythmias, severe angina, or myocardial infarction within the previous 4 weeks
  • If female, non-pregnant, as confirmed by urine human chorionic gonadotropin (HCG) test
  • Only one member per household will be enrolled. If more than one member is interested, the member whose birthday is closest to date of enrollment will be chosen. Once 12 month data collection is completed for the participant, cessation materials/referral to the Ohio Quit Line will be offered to other interested family member(s).

排除标准

  • Under 18 years of age
  • Non-daily use of tobacco (self-reported)
  • Not a resident of one of the 12 participating counties
  • Presences of clinical condition that contraindicates use of over-the-counter NRT, including: severe arrhythmias, severe angina, or myocardial infarction within the previous 4 weeks
  • If female, pregnant, as confirmed by urine human chorionic gonadotropin (HCG) test

结局指标

主要结局

Self-reported tobacco abstinence in past 7 days as confirmed by saliva cotinine concentration < 15ng/ml

时间窗: 12 months

At the 12 month time point, tobacco abstinence (past 7 days) will be assessed using self-reported data. Saliva cotinine concentration of less than 15ng/ml will confirm as abstinence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Ellen Wewers

Professor Emerita

Ohio State University

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