Assessing Telephone All Nations Breath of Life for Efficacy

项目摘要 在美国所有主要种族中，AI的吸烟率最高，为31.8%，几乎是两者的两倍 非裔美国人和白人。尽管吸烟率很高，但很少有研究人员对此进行研究。 问题，部分原因是烟草是许多人工智能的神圣植物，不能完全消极对待， 大多数戒烟计划都是这样的。堪萨斯大学医学中心（KUMC）的研究人员和 约翰逊县社区学院（JCCC）一直在与区域合作伙伴合作，利用社区- 自2003年以来，我们一直在进行基于参与性研究（CBPR）的研究，以解决娱乐性烟草问题。我们已经开发出一种 成功的文化定制计划，所有国家的生命呼吸（ANBL），尊重烟草作为一个神圣的 种植和促进尊重它，而不是滥用它的娱乐。我们的面对面，以小组为基础的计划 治疗结束时的意向性治疗退出率为27.9%，与目前的最佳实践相比为17.4%（12 周）在基于预约的疗效试验（N=463）。6个月时的停药率为20% vs. 12%（p=0.02）。中 大型城市实施可行性研究（N=312，横跨5个州），6个月时戒烟率为22 （与先前报道的城市AI人群的最高比率相比，p<0.002）;保留率为71%。 根据社区的要求，我们创建了一个基于电话的程序版本， tANBL，对N=33人进行了初步测试，6个月时的戒烟率为24.2%，假设 作为吸烟者失访。该计划在6个月时的留存率为81.8%。我们现在准备 正式测试tANBL的有效性;这是使用贝叶斯自适应设计（BAD）和我们的 社区参与式研究（CBPR）。我们将实现以下具体目标：（1） 为了将tANBL与个人非定制的基于电话的比较程序（CP）进行比较， 贝叶斯自适应设计（n=500）;（2）检查实施 个人电话为基础的ANB和（3）比较个人电话ANBL与个人非定制 使用贝叶斯自适应设计的基于电话的比较程序（N=500）。我们的主要终点将 通过唾液可替宁生化验证的7天点戒烟率 基线后6个月的水平。ANBL计划的退出率将明显优于非ANBL计划。 量身定制的方案（24%对10%）。我们将解决以下次要目标：（1）比较tANBL 和基线后6个月和12个月的CP 30天时点患病率和持续戒烟率; (2)检查个体因素，如药物治疗类型（如有）、成瘾程度、使用其他药物 尼古丁产品，如电子烟，戒烟史，动机，烟草健康知识，社会支持，自我， 疗效、种族认同、心理社会健康和人口统计学因素对戒烟率的影响;（3）最大化 并评估干预计划及其所有组成部分的文化相关性;（4）识别 增强基于电话的ANBL的传播并有助于计划成功或失败的因素。

PROJECT SUMMARY AI have the highest smoking rates of all major ethnic groups in the US, at 31.8%, nearly double that of both African Americans and Whites. Despite these high rates of smoking, few researchers have addressed this issue, in part because tobacco is a sacred plant to many AI and cannot be treated completely negatively, as most smoking cessation programs do. Researchers at the University of Kansas Medical Center (KUMC) and Johnson County Community College (JCCC) have been working with regional partners using community- based participatory research (CBPR) to address recreational tobacco since 2003. We have developed a successful culturally tailored program, All Nations Breath of Life (ANBL), that respects tobacco as a sacred plant and promotes honoring it rather than abusing it recreationally. Our in-person, group-based program had an intent-to-treat quit rate of 27.9% versus 17.4% compared to current best practices at end of treatment (12 weeks) in a reservation-based efficacy trial (N=463). Cessation was 20% vs. 12% at 6 months (p=0.02). In a large urban implementation feasibility study (N=312 across five states), the quit rate was 22% at 6-months (p<0.002 compared to the highest previously reported rates for an urban AI population); retention was 71%. Based on a request from the community, we created an individual telephone-based version of the program, tANBL, which was pilot tested with N=33 individuals and had a 24.2% quit rate at 6 months, assuming those lost to follow-up as smokers. The program had an 81.8% retention rate at 6 months. We are now ready to formally test tANBL for efficacy; that is proposed here using a Bayesian Adaptive Design (BAD) and our community-based participatory research (CBPR) framework. We will address the following specific aims: (1) To compare tANBL with an individual non-tailored telephone-based comparison program (CP) using a Bayesian Adaptive Design (n=500); (2) To examine the acceptability and feasibility of implementing an individual telephone-based ANB and (3) To compare individual telephone ANBL with an individual non-tailored telephone-based comparison program using a Bayesian Adaptive Design (N=500). Our primary endpoint will be 7-day point prevalence abstinence from recreational smoking biochemically verified by salivary cotinine level at 6 months post-baseline. Quit rates in the ANBL program will be significantly better than in the non- tailored program (24% versus 10%). We will address the following secondary aims: (1) To compare tANBL and CP 30-day point prevalence and continuous abstinence rates at 6 months and 12 months post-baseline; (2) To examine individual factors such as type of pharmacotherapy (if any), level of addiction, use of other nicotine products such as e-cigarettes, quitting history, motivation, tobacco health literacy, social support, self- efficacy, ethnic identity, psychosocial health and demographic factors for effect on quit rates; (3) To maximize and assess the cultural relevance of the intervention program and all of its components and (4) To identify factors that enhance dissemination of telephone-based ANBL and contribute to program success or failure.