Clinical trial NCT02773836: European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
Official title: European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Dependence
Keywords: tobacco use
e-cigarettes
public policy
ITC
Lead sponsor: European Network For Smoking and Tobacco Prevention
Sponsor class: OTHER
Collaborators: name: King's College London
name: German Cancer Research Center
name: Maastricht University
name: University of Athens
name: AER PUR ROMANIA
name: European Respiratory Society
name: University of Waterloo
name: Institut Català d'Oncologia
name: DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY
name: PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA
name: University of Crete
name: TNS OPINION SA
First posted: 2016-05-16
Enrollment: 6036
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of 1,000 smokers recruited in each of 6 European Member States (n=6,000 in total), to be recruited at baseline.

Brief summary: 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

Detailed description: 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.

Sampling households within clusters:

* Interviewers will employ a random walk procedure within a particular cluster
* Once interviewers have arrived at an address, the household will be approached four times at different times of the day and week before being designated as "unable to be contacted."
* If an address corresponds to multiple households, a single household will be chosen at random.
* Households are approached until a total of 4 adult smokers have been reached within the cluster. A maximum of one male smoker and one female smoker will be selected for interview in each household.
* One male and one female from within the household that meet the criteria will be selected using the last birthday method

Respondents:

* The respondents for the Survey will be smokers aged 18 and older. The first part of the survey, which is the household screener, contains the questions that are used to determine whether the household has members that meet the criteria for inclusion.

  * The household screener is asked of the most knowledgeable individual (MKI) within the household.
  * One male and one female from within the household that meet the criteria will be selected using the last birthday method.
* The Individual screener follows the Household screener and confirms the information from the MKI is accurate. If the selected individual meets the eligibility criteria and consents to participate, they will be included in the sample

Survey (questionnaire):

The questionnaire will include questions not only about tobacco use, history of use, history of quitting, quit method(s) used, measures of dependence, and demographics (age, gender, education, income) but also extensive, theory-based measures of responsiveness to each policy domain of the FCTC. The survey questionnaire will consist of:

1. multiple measures of policy-specific variables for each of the domains of the TPD and FCTC (e.g., health warnings, additives, e-cigarettes for TPD, illicit trade; additional domains of the FCTC, including smoke-free laws, tax/price policies, cessation services, additional product regulation domains);
2. psychosocial mediators, identified by past research and theory to predict future health behaviours, including beliefs and attitudes, perceived risk, intentions to quit;
3. moderators such as demographic variables (sex, gender), and other variables that will allow analyses of whether TPD and FCTC policies vary in their impact as a function of socioeconomical status.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Inability to complete the questionnaire due to health/mental incapability.
* Unable to provide consent to participate.

Primary outcomes:
measure: Number of Participants Who Think About the Harm of Smoking
timeFrame: Baseline Pre-TPD
measure: Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Think About How Much They Enjoy Smoking by Frequency
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Have Ever Tried to Quit Smoking
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Plan to Quit Smoking
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Think About the Harm of Smoking
timeFrame: Post-TPD
measure: Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
timeFrame: Post-TPD
measure: Number of Participants Who Have Ever Tried to Quit Smoking
timeFrame: Post-TPD
measure: Number of Participants Who Plan to Quit Smoking
timeFrame: Post-TPD
Secondary outcomes:
measure: Number of Participants Who Think About The Money They Spend on Smoking
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
timeFrame: Baseline Pre-TPD
measure: Number of Participants Who Think About The Money They Spend on Smoking
timeFrame: Post-TPD
measure: Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
timeFrame: Post-TPD
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: European Network For Smoking and Tobacco Prevention
Study officials:
affiliation: European Network For Smoking and Tobacco Prevention
name: Constantine Vardavas, MD,RN,MPH,PHD
role: PRINCIPAL_INVESTIGATOR
References: