Assessing Telephone All Nations Breath of Life for Efficacy

评估电话万国生命之息的功效

基本信息

批准号：
10240739
负责人：
CHRISTINE Makosky DALEY
金额：
$ 67.02万
依托单位：
LEHIGH UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10240739
关键词：
Abstinence Address African American American Indians Anthropology Bayesian Modeling Behavioral Biochemical Biometry Cancer Etiology Cardiovascular Diseases Cause of Death Cessation of life Communities Community Participation Cotinine County Demographic Factors Education Electronic cigarette Epidemiology Ethnic group Failure Family Practice Feasibility Studies Future Geographic Locations Goals Health Individual Intervention Kansas Letters Life Malignant neoplasm of lung Medical center Methods Motivation Nicotine Outcome Persons Pharmacotherapy Plants Population Premature Mortality Prevalence Recording of previous events Reporting Research Research Methodology Research Personnel Risk Factors Salivary Self Efficacy Smoker Smoking Social support Telephone Testing Tobacco Tobacco use United States Universities acceptability and feasibility addiction base cigarette smoking community based participatory research community college community organizations efficacy testing efficacy trial enhancing factor ethnic identity follow-up health disparity health literacy implementation study intervention program primary endpoint programs psychosocial quitline recruit reservation-based response retention rate smoking cessation success tobacco control urban Native American

项目摘要

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.

项目概要 AI在美国所有主要族裔中吸烟率最高，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，但很少有研究人员解决这个问题问题的部分原因是烟草对许多人工智能来说是一种神圣的植物，不能完全消极地对待，因为大多数戒烟计划都是如此。堪萨斯大学医学中心 (KUMC) 的研究人员约翰逊县社区学院 (JCCC) 一直与区域合作伙伴合作，利用社区- 自 2003 年以来，我们开展了基于参与式研究 (CBPR) 的研究来解决休闲烟草问题。我们开发了一种成功的文化定制计划“万国生命之息”(ANBL)，将烟草视为神圣的事物种植并提倡尊重它，而不是娱乐性地滥用它。我们的面对面、以小组为基础的计划有治疗结束时，与当前最佳实践相比，意向治疗戒烟率为 27.9% 和 17.4%（12 周）在基于预约的疗效试验中（N = 463）。 6 个月时戒烟率为 20% vs. 12% (p=0.02)。在一个大型城市实施可行性研究（N=312，跨越五个州），6 个月时戒烟率为 22% （与之前报道的城市人工智能人口的最高比率相比，p<0.002）；保留率为 71%。根据社区的要求，我们创建了该程序的个人电话版本， tANBL，在 N=33 个人中进行了试点测试，6 个月时的戒烟率为 24.2%（假设作为吸烟者失去了随访。该计划 6 个月后的保留率为 81.8%。我们现在准备好正式测试 tANBL 的功效；这里建议使用贝叶斯自适应设计（BAD）和我们的基于社区的参与性研究（CBPR）框架。我们将实现以下具体目标：（1）使用以下方法将 tANBL 与单个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) 审查实施的可接受性和可行性基于个人电话的 ANB 以及 (3) 将个人电话 ANBL 与个人非定制的 ANB 进行比较使用贝叶斯自适应设计的基于电话的比较程序 (N=500)。我们的主要终点将是通过唾液可替宁生化验证的 7 天点戒烟流行率基线后 6 个月的水平。 ANBL 计划中的戒烟率将明显高于非计划中的戒烟率。量身定制的计划（24% 对 10%）。我们将解决以下次要目标：（1）比较 tANBL CP 30 天点患病率和基线后 6 个月和 12 个月的持续戒断率； (2) 检查个体因素，例如药物治疗类型（如有）、成瘾程度、使用其他药物电子烟等尼古丁产品、戒烟历史、动机、烟草健康素养、社会支持、自我戒烟影响戒烟率的功效、种族认同、社会心理健康和人口因素； (3) 最大化评估干预计划及其所有组成部分的文化相关性，以及 (4) 确定加强基于电话的 ANBL 传播并促成计划成功或失败的因素。