Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
研究概览
简要总结
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
详细描述
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •AI race based on self-report;
- •≥ 18 years of age via photo ID confirmation;
- •Average smoked cigarettes per day, ≥ 3 in the past 30 days;
- •considering or willing to make a quit attempt;
- •self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
- •able to read and speak English.
排除标准
- 未提供
研究组 & 干预措施
Tailored
Tailored texting program for quit smoking
干预措施: Cultural Smoking Cessation Program (Other)
Standard
Standard texting program for quit smoking
干预措施: Smoking Cessation Program (Other)
结局指标
主要结局
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
时间窗: 6 months
Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days \[not even a puff of cigarettes, cigars, hookah, or pipe tobacco\] with a negative breath CO test ≤ 4 ppm).
次要结局
- Percent of participants that are biochemically-confirmed 7-day abstinence(1 and 3 months)
- Percent of participants that self-report 24-hour abstinence(1, 3, and 6 months)
- Percent of participants that self-report 7-day abstinence(1, 3, and 6 months)
- Percent of participants that self-report 30-day abstinence(3 and 6 months)
- Mean cigarettes per day in past 7 days(1, 3, and 6 months)
- Number of 24-hour quit attempts in past 30 days(1, 3, and 6 months)
- Percent of participants that used nicotine replacement therapy and pharmacotherapy(1, 3, and 6 months)
- Percent of participants that used other behavioral support(1, 3, and 6 months)
- Percent of participants that used other commercial tobacco products(1, 3, and 6 months)
- Mean cigarette dependence(1, 3, and 6 months)