European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)

Tobacco Dependence Clinical Trial

— EUREST-PLUS  

Official title:

European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773836
• Other study ID #: 681109
• Status: Completed
• Start date: June 15, 2016
• Est. completion date: May 6, 2018

Study information

• Verified date: February 2019
• Source: European Network For Smoking and Tobacco Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6036
• Est. completion date: May 6, 2018
• Est. primary completion date: September 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Other:
• Questionnaire
Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)

Locations

Country	Name	City	State
Belgium	European Network For Smoking and Tobacco Prevention	Brussels

Sponsors (13)

Lead Sponsor	Collaborator
European Network For Smoking and Tobacco Prevention	AER PUR ROMANIA, DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY, European Respiratory Society, German Cancer Research Center, Institut Català d'Oncologia, King's College London, Maastricht University, PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA, TNS OPINION SA, University of Athens, University of Crete, University of Waterloo

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Think About the Harm of Smoking	In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses: Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Baseline Pre-TPD
Primary	Number of Participants Whose First Cigarette After Waking is 30 Mins or Less	How soon after waking do you usually have your first smoke? responses: 5 min or less; 6-30 min; 31-60 min; More than 60 min	Baseline Pre-TPD
Primary	Number of Participants Who Think About How Much They Enjoy Smoking by Frequency	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?; Never; Rarely; Sometimes; Often; Very often; Refused; Don't know	Baseline Pre-TPD
Primary	Number of Participants Who Have Ever Tried to Quit Smoking	Have you ever tried to quit smoking?; Yes; No; 8 Refused 9 Don't know	Baseline Pre-TPD
Primary	Number of Participants Who Plan to Quit Smoking	Are you planning to quit smoking . . .; Within the next month; Within the next 6 months; Sometime in the future, beyond 6 months; Or are you not planning to quit?; 8 Refused 9 Don't know	Baseline Pre-TPD
Primary	Number of Participants Who Think About the Harm of Smoking	In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses: Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Post-TPD
Primary	Number of Participants Whose First Cigarette After Waking is 30 Mins or Less	How soon after waking do you usually have your first smoke? responses: 5 min or less; 6-30 min; 31-60 min; More than 60 min	Post-TPD
Primary	Number of Participants Who Have Ever Tried to Quit Smoking	Have you ever tried to quit smoking?; Yes; No; 8 Refused 9 Don't know	Post-TPD
Primary	Number of Participants Who Plan to Quit Smoking	Are you planning to quit smoking . . .; Within the next month; Within the next 6 months; Sometime in the future, beyond 6 months; Or are you not planning to quit?; 8 Refused 9 Don't know	Post-TPD
Secondary	Number of Participants Who Think About The Money They Spend on Smoking	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 the money you spend on smoking?; Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Baseline Pre-TPD
Secondary	Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People	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 the harm your smoking might be doing to other people?; Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Baseline Pre-TPD
Secondary	Number of Participants Who Think About The Money They Spend on Smoking	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 the money you spend on smoking?; Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Post-TPD
Secondary	Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People	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 the harm your smoking might be doing to other people?; Never; Rarely; Sometimes; Often; Very often; 8 Refused 9 Don't know	Post-TPD

External Links

•   Project website