Assessing Telephone All Nations Breath of Life for Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Cessation
研究概览
简要总结
This project formally test an individual, telephone-based version of the All Nations Breath of Life smoking cessation program (tANBL) for American Indians (AI) for efficacy versus an untailored comparison program (CP). The primary outcome is 7-day point prevalence abstinence from smoking cigarettes at 6 months post-baseline. Secondarily, the study examines continuous abstinence and reduction in smoking at both 6 and 12 months post-baseline, as well as demographic predictors of cessation and/or reduction.
详细描述
The study uses a Bayesian Adaptive Design to examine efficacy of tANBL versus a non-tailored comparison program (CP). All participants will be offered individual telephone counseling, motivational text messaging, educational materials, and the choice of taking pharmacotherapy (must be obtained by participant). Participants in tANBL will receive the culturally tailored versions of all aspects of the program; participants in CP will receive non-tailored versions.
Telephone All Nations Breath of Life (tANBL) Intervention Components
Primary components of tANBL and modifications from the original program are described below:
Individual Sessions: The primary component of tANBL will be a series of individual support sessions, led by an AI facilitator. Community members will be trained in cessation support and counseling. All sessions begin with discussion of individual experiences. All facilitators can be given an extension on the study team's toll-free line, which can be used from any computer. Facilitators will track calls, who participates, how long they last, and recordings (for supervision and training). Facilitators will, in part, use Motivational Interviewing (MI), which has been found effective among AI, enhances motivation for change, and is based on the assumption that many with addictions are not ready to change. The goal is to increase motivation through discrepancy between current behavior and goals/values. The study team developed culturally sensitive counseling scripts to explore positive and negative aspects of, participants' motivation and confidence for quitting smoking, the pros and cons, and plans for change. Participants are asked to identify their values and explore connections between smoking and their ability to live out their values. Participants who score lower on motivation and confidence at each session will be given more Motivational Interviewing.
Text Messaging: Between phone calls, participants receive motivational culturally tailored text messaging, including messages about why smoking is detrimental to health, respecting the sacred nature of tobacco, simple motivational messages to continue trying to quit or stay quit, etc., based on the educational curriculum. The study team has a database of motivational messages developed during the pilot of tANBL; the team will develop and add more messages throughout program implementation to keep messaging relevant and fresh.
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
- 是
入选标准
- •Age 18 or older
- •Self-reported American Indian
- •Smokes at least 1 cigarette per day
- •Have a home address or stable address to which we can mail program supplies
- •Have a stable telephone number that can be used for the purpose of the study
- •Willing to be followed for 12 months
排除标准
- •Cannot provide a stable phone number for the purpose of the study that will be available for a minimum of 12 months
- •Household member already in the study
研究组 & 干预措施
Telephone All Nations Breath of Life
This is a culturally targeted smoking cessation program developed for American Indian communities. It includes individual telephone counseling, text messaging, and educational materials.
干预措施: Telephone All Nations Breath of Life (Behavioral)
Comparison Program
This is a non-culturally targeted smoking cessation program. It includes individual counseling, text messaging, and educational materials.
干预措施: Comparison Program (Behavioral)
结局指标
主要结局
Cessation
时间窗: 6 months
7-day point prevalence abstinence from smoking cigarettes
次要结局
- Smoking Change(6 months, 12 months)
- Cessation(12 months)
- Continuous Cessation(6 months, 12 months)
