Assessing the Effectiveness of a Smoke-Free Home Program in Tribal Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 575
- 试验地点
- 2
- 主要终点
- Self-Reported Smoke-Free Home
研究概览
简要总结
This clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. Smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. Rural and racial/ethnic inequities intersect to increase tobacco-related harms among Indigenous populations. A smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.
详细描述
PRIMARY OBJECTIVE:
I. To assess the effectiveness of a smoke-free homes intervention for tribal communities.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2.
GROUP II: Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.
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
- Single (Outcomes Assessor)
盲法说明
Randomization will be supervised by the study statistician and data collection staff will be blind to group assignment.
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
- •18 years of age and older
- •Self-report as being a smoker or living with a smoker
- •Indicate that they do not reside in a smoke-free home
- •Identify as living in an American Indian household
排除标准
- •Children under the age of 18 will not be included
结局指标
主要结局
Self-Reported Smoke-Free Home
时间窗: At 3 and 6 months
Which statement best describes rules about smoking inside your home? There are no rules about smoking inside your home? Smoking is not allowed anywhere inside your home? Smoking is allowed in some places or at some times in your home? Smoking is allowed anywhere inside your home? Those answering that smoking is not allowed anywhere inside their home are classified as having a smoke-free home. It will be self-reported \& measured using air nicotine monitor from a subset of 20% participants to assess validity of the self-report, adjusting for possible traditional uses of tobacco and use of electronic cigarettes. Receiver-operator curve analysis to determine the optimal thresholds for a smoke-free home \& complete case data, two-level logistic multilevel models accounting for nesting of participants in tribal communities with group assignment predicting a binary smoke-free home status (full ban/no full ban).
次要结局
- Smoke-Free Vehicles Assessed Via Telephone Interview(At 3 and 6 months)
- Secondhand Smoke (SHS) Exposure In The Home Assessed via Telephone Interview(At 3 and 6 months)
- Number of Cigarettes Smoked In the Home(At 3 and 6 months)
- Public Support for Smoke-Free Tribal Housing Assessed Via Telephone Interview(At 3 and 6 months)
研究者
Michelle C. Kegler
Principal Investigator
Emory University