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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 12, 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • Greek cohort
    • Participants recruited from Greece will receive a questionnaire at pre- and post- intervention
  • German cohort
    • Participants recruited from Germany will receive a questionnaire at pre- and post- intervention
  • Romanian Cohort
    • Participants recruited from Romania will receive a questionnaire at pre- and post- intervention
  • Spanish Cohort
    • Participants recruited from Spain will receive a questionnaire at pre- and post- intervention
  • Hungarian Cohort
    • Participants recruited from Hungary will receive a questionnaire at pre- and post- intervention
  • Polish cohort
    • Participants recruited from Poland will receive a questionnaire at pre- and post- intervention

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants Who Think About the Harm of Smoking
    • Time Frame: Baseline Pre-TPD
    • 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
  • Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
    • Time Frame: Baseline Pre-TPD
    • 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
  • Number of Participants Who Think About How Much They Enjoy Smoking by Frequency
    • Time Frame: 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? Never Rarely Sometimes Often Very often Refused Don’t know
  • Number of Participants Who Have Ever Tried to Quit Smoking
    • Time Frame: Baseline Pre-TPD
    • Have you ever tried to quit smoking? Yes No 8 Refused 9 Don’t know
  • Number of Participants Who Plan to Quit Smoking
    • Time Frame: Baseline Pre-TPD
    • 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
  • Number of Participants Who Think About the Harm of Smoking
    • Time Frame: Post-TPD
    • 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
  • Number of Participants Whose First Cigarette After Waking is 30 Mins or Less
    • Time Frame: Post-TPD
    • 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
  • Number of Participants Who Have Ever Tried to Quit Smoking
    • Time Frame: Post-TPD
    • Have you ever tried to quit smoking? Yes No 8 Refused 9 Don’t know
  • Number of Participants Who Plan to Quit Smoking
    • Time Frame: Post-TPD
    • 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

Secondary Measures

  • Number of Participants Who Think About The Money They Spend on Smoking
    • Time Frame: 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 the money you spend on smoking? Never Rarely Sometimes Often Very often 8 Refused 9 Don’t know
  • Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
    • Time Frame: 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 the harm your smoking might be doing to other people? Never Rarely Sometimes Often Very often 8 Refused 9 Don’t know
  • Number of Participants Who Think About The Money They Spend on Smoking
    • Time Frame: Post-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 the money you spend on smoking? Never Rarely Sometimes Often Very often 8 Refused 9 Don’t know
  • Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People
    • Time Frame: Post-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 the harm your smoking might be doing to other people? Never Rarely Sometimes Often Very often 8 Refused 9 Don’t know

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • European Network For Smoking and Tobacco Prevention
  • Collaborator
    • King’s College London
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Constantine Vardavas, MD,RN,MPH,PHD, Principal Investigator, European Network For Smoking and Tobacco Prevention

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