European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,036
- 试验地点
- 1
- 主要终点
- Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
研究概览
简要总结
The main objective of EUREST-PLUS is to monitor and evaluate the impact of the Tobacco Products Directive (TPD) within the context of FCTC ratification at an EU level. The investigators specific objectives, within WorkPackage 2 and Workpackage 3 are: To evaluate the psychosocial and behavioral impact of TPD implementation and FCTC implementation, through the creation of a cohort study of adult smokers in 6 European Member States (EU MS), Germany, Greece, Hungary, Poland, Romania, Spain; (total n=6000) in a pre- vs. post-TPD study design.
EUREST-PLUS is funded through the European Union's Horizon 2020 research and innovation programme under grant agreement No 681109
详细描述
Smoking and other forms of tobacco consumption are considered the single most important cause of preventable morbidity and premature mortality worldwide, with tobacco the major single cause for premature deaths in the European Union (EU).Efforts to reduce the devastation of tobacco-related deaths and illness in the EU consist of its newly adopted binding legislation, the Tobacco Products Directive (TPD), and the ongoing implementation of the WHO Framework Convention on Tobacco Control (FCTC).
Objective:
The main objective of EUREST-PLUS is to monitor and evaluate the psychosocial and behavioral impact of the TPD within the context of FCTC ratification at a European level, through the creation of a cohort study of adult smokers in 6 EU MS (Germany, Greece, Hungary, Poland, Romania, Spain; total n=6000) in a pre- vs. post-TPD study design. The baseline recruitment will take place in WP2 and the follow up in WP3.
Sampling frames:
- The sampling frame will be determined through a national probability sampling design within each country.
- Sample stratification will be geographic and comprise the major regions of each country (Nomenclature of Territorial Units for Statistics - NUTS) NUTS2 (Basic regions for the application of regional policies) will be used for all countries except Germany - where NUTS1 (Major socio-economic regions) will be used, as well as degrees of urbanization (city/town/rural.)
- Geographic areas excluded from the sampling design will be: In Greece, the islands in the Ionian Sea, the northern Aegean Sea and the southern Aegean Sea. In Spain the Canaries, Ceuta and Melilla
- Overall the design will be multistage within strata. The strata will be conceptually divided into clusters, each the size of an enumeration area, with the objective of sampling a total of 250 clusters - 4 adult smokers per cluster in every country.
- Clusters will be allocated based on population size and sampled via random sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Must be 18 years of age or older.
- •Must smoke at least monthly.
- •Must have smoked 100 cigarettes in their lifetime.
- •Must live in the household visited
排除标准
- •Inability to complete the questionnaire due to health/mental incapability.
- •Unable to provide consent to participate.
结局指标
主要结局
Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
时间窗: Post-TPD
How soon after waking do you usually have your first smoke? responses: 1. 5 min or less 2. 6-30 min 3. 31-60 min 4. More than 60 min
Number of Participants Who Think About How Much They Enjoy Smoking by Frequency
时间窗: Baseline Pre-TPD
The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you . . . Think about how much you enjoy smoking? 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 6. Refused 7. Don't know
Number of Participants Who Think About the Harm of Smoking
时间窗: Post-TPD
In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses: 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 8 Refused 9 Don't know
Number of Participants Who Have Ever Tried to Quit Smoking
时间窗: Post-TPD
Have you ever tried to quit smoking? 1. Yes 2. No 8 Refused 9 Don't know
Number of Participants Who Plan to Quit Smoking
时间窗: Post-TPD
Are you planning to quit smoking . . . 1. Within the next month 2. Within the next 6 months 3. Sometime in the future, beyond 6 months 4. Or are you not planning to quit? 8 Refused 9 Don't know
次要结局
- Number of Participants Who Think About The Money They Spend on Smoking(Post-TPD)
- Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People(Post-TPD)