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| Name | Class |
|---|---|
| King's College London | OTHER |
| German Cancer Research Center | OTHER |
| Maastricht University | OTHER |
| University of Athens |
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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
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:
Sampling households within clusters:
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 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
8 Refused 9 Don't know | Baseline Pre-TPD |
| 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:
| Baseline Pre-TPD |
| 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?
| Baseline Pre-TPD |
| Number of Participants Who Have Ever Tried to Quit Smoking | Have you ever tried to quit smoking?
8 Refused 9 Don't know | Baseline Pre-TPD |
| Number of Participants Who Plan to Quit Smoking | Are you planning to quit smoking . . .
8 Refused 9 Don't know | Baseline Pre-TPD |
| 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:
8 Refused 9 Don't know |
| Measure | Description | Time Frame |
|---|---|---|
| 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?
8 Refused 9 Don't know | Baseline Pre-TPD |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort of 1,000 smokers recruited in each of 6 European Member States (n=6,000 in total), to be recruited at baseline.
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| Name | Affiliation | Role |
|---|---|---|
| Constantine Vardavas, MD,RN,MPH,PHD | European Network For Smoking and Tobacco Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Network For Smoking and Tobacco Prevention | Brussels | 1050 | Belgium |
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The reason there are more participants enrolled at Period 2 (Wave 2 Post-TPD implementation) as compared to Period 1 (Wave 1 Pre-TPD implementation) is because a replenishment sample was recruited in Wave 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Greek Cohort | Participants recruited from Greece Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| FG001 | German Cohort | Participants recruited from Germany Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| FG002 | Romanian Cohort | Participants recruited from Romania Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| FG003 | Spanish Cohort | Participants recruited from Spain Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| FG004 | Hungarian Cohort | Participants recruited from Hungary Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| FG005 | Polish Cohort | Participants recruited from Poland Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wave 1- Pre-TPD Implementation |
| |||||||||||||
| Wave 2- Post-TPD Implementation |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Greek Cohort | Participants recruited from Greece Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG001 | German Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
8 Refused 9 Don't know | Posted | Count of Participants | Participants | Baseline Pre-TPD |
|
Adverse event data was not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Greek Cohort | Participants recruited from Greece Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Constantine Vardavas | European Network for Smoking and Tobacco Prevention | +306937281680 | vardavas@tobcontrol.eu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 1, 2017 | Feb 19, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
| AER PUR ROMANIA | UNKNOWN |
| European Respiratory Society | OTHER |
| University of Waterloo | OTHER |
| Institut Català d'Oncologia | OTHER |
| DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY | UNKNOWN |
| PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA | UNKNOWN |
| University of Crete | OTHER |
| TNS OPINION SA | UNKNOWN |
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|
| Post-TPD |
| 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:
| Post-TPD |
| Number of Participants Who Have Ever Tried to Quit Smoking | Have you ever tried to quit smoking?
8 Refused 9 Don't know | Post-TPD |
| Number of Participants Who Plan to Quit Smoking | Are you planning to quit smoking . . .
8 Refused 9 Don't know | Post-TPD |
| 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?
8 Refused 9 Don't know | Baseline Pre-TPD |
| 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?
8 Refused 9 Don't know | Post-TPD |
| 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?
8 Refused 9 Don't know | Post-TPD |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants recruited from Germany Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG002 | Romanian Cohort | Participants recruited from Romania Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG003 | Spanish Cohort | Participants recruited from Spain Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG004 | Hungarian Cohort | Participants recruited from Hungary Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG005 | Polish Cohort | Participants recruited from Poland Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number of Cigarettes/E-cigarettes Smoked per day by participants | How many cigarettes/E-cigarettes do you smoke per day? Collected via questionnaire Cigarettes/day (all current smokers) | Mean | Standard Deviation | cigarettes per day |
|
| OG002 | Romanian Cohort | Participants recruited from Romania Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| OG003 | Spanish Cohort | Participants recruited from Spain Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| OG004 | Hungarian Cohort | Participants recruited from Hungary Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
| OG005 | Polish Cohort | Participants recruited from Poland Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) |
|
|
| 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:
| Posted | Count of Participants | Participants | 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?
| Posted | Count of Participants | Participants | Baseline Pre-TPD |
|
|
|
| Primary | Number of Participants Who Have Ever Tried to Quit Smoking | Have you ever tried to quit smoking?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | Baseline Pre-TPD |
|
|
|
| Primary | Number of Participants Who Plan to Quit Smoking | Are you planning to quit smoking . . .
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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:
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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:
| Posted | Count of Participants | Participants | Post-TPD |
|
|
|
| Primary | Number of Participants Who Have Ever Tried to Quit Smoking | Have you ever tried to quit smoking?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | Post-TPD |
|
|
|
| Primary | Number of Participants Who Plan to Quit Smoking | Are you planning to quit smoking . . .
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | 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?
8 Refused 9 Don't know | Posted | Count of Participants | Participants | Post-TPD |
|
|
|
| 0 |
| 1,000 |
| 0 |
| 1,000 |
| 0 |
| 1,000 |
| EG001 | German Cohort | Participants recruited from Germany Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | 0 | 1,003 | 0 | 1,003 | 0 | 1,003 |
| EG002 | Romanian Cohort | Participants recruited from Romania Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | 0 | 1,001 | 0 | 1,001 | 0 | 1,001 |
| EG003 | Spanish Cohort | Participants recruited from Spain Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | 0 | 1,001 | 0 | 1,001 | 0 | 1,001 |
| EG004 | Hungarian Cohort | Participants recruited from Hungary Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | 0 | 1,000 | 0 | 1,000 | 0 | 1,000 |
| EG005 | Polish Cohort | Participants recruited from Poland Questionnaire: Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC) | 0 | 1,006 | 0 | 1,006 | 0 | 1,006 |
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| D012907 |
| Smoking |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 31-60 minutes |
|
| 6-30 minutes |
|
| 5 minutes or less |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very often |
|
| Refused |
|
| Don't Know |
|
| No |
|
| Refused |
|
| Don't know |
|
| Within the next 6 months |
|
| Sometime in the future, beyond 6 months |
|
| Or are you not planning to quit? |
|
| Refused |
|
| Don't know |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very Often |
|
| Don't Know |
|
| Refused |
|
| 6-30 minutes |
|
| 31-60 minutes |
|
| More than 60 minutes |
|
| Don't know |
|
| Never tried to quit |
|
| Within the next 6 months |
|
| Sometime in the future, beyond 6 months |
|
| Or are you not planning to quit |
|
| Refused |
|
| Don't know |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very often |
|
| Refused |
|
| Don't Know |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very often |
|
| Refused |
|
| Don't Know |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very Often |
|
| Refused |
|
| Don't know |
|
| Rarely |
|
| Sometimes |
|
| Often |
|
| Very Often |
|
| Refused |
|
| Don't know |
|