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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773836
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
King's College London
German Cancer Research Center
Maastricht University
University of Athens
AER PUR ROMANIA
European Respiratory Society
University of Waterloo
Institut Català d'Oncologia
DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY
PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA
University of Crete
TNS OPINION SA
Information provided by (Responsible Party):
European Network For Smoking and Tobacco Prevention

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


Condition or disease Intervention/treatment
Tobacco Dependence Other: Questionnaire

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 6036 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Regulatory Science on Tobacco: Policy Implementation to Reduce Lung Diseases (EUREST-PLUS)
Actual Study Start Date : June 15, 2016
Actual Primary Completion Date : September 12, 2016
Actual Study Completion Date : May 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort Intervention/treatment
Greek cohort
Participants recruited from Greece will receive a questionnaire at pre- and post- 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)

German cohort
Participants recruited from Germany will receive a questionnaire at pre- and post- 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)

Romanian Cohort
Participants recruited from Romania will receive a questionnaire at pre- and post- 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)

Spanish Cohort
Participants recruited from Spain will receive a questionnaire at pre- and post- 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)

Hungarian Cohort
Participants recruited from Hungary will receive a questionnaire at pre- and post- 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)

Polish cohort
Participants recruited from Poland will receive a questionnaire at pre- and post- 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)




Primary Outcome Measures :
  1. 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:

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know


  2. 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:

    1. 5 min or less
    2. 6-30 min
    3. 31-60 min
    4. More than 60 min

  3. 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?

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often
    6. Refused
    7. Don't know

  4. Number of Participants Who Have Ever Tried to Quit Smoking [ Time Frame: Baseline Pre-TPD ]

    Have you ever tried to quit smoking?

    1. Yes
    2. No

    8 Refused 9 Don't know


  5. Number of Participants Who Plan to Quit Smoking [ Time Frame: Baseline Pre-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


  6. 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:

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know


  7. 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:

    1. 5 min or less
    2. 6-30 min
    3. 31-60 min
    4. More than 60 min

  8. Number of Participants Who Have Ever Tried to Quit Smoking [ Time Frame: Post-TPD ]

    Have you ever tried to quit smoking?

    1. Yes
    2. No

    8 Refused 9 Don't know


  9. Number of Participants Who Plan to Quit Smoking [ Time Frame: 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



Secondary Outcome Measures :
  1. 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?

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know


  2. 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?

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know


  3. 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?

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know


  4. 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?

    1. Never
    2. Rarely
    3. Sometimes
    4. Often
    5. Very often

    8 Refused 9 Don't know




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773836


Locations
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Belgium
European Network For Smoking and Tobacco Prevention
Brussels, Belgium, 1050
Sponsors and Collaborators
European Network For Smoking and Tobacco Prevention
King's College London
German Cancer Research Center
Maastricht University
University of Athens
AER PUR ROMANIA
European Respiratory Society
University of Waterloo
Institut Català d'Oncologia
DOHANYZAS VAGY EGESZSEG MAGYAR ALAPITVANY
PROMOCJA ZDROWIA - ZDROWIE ALBO TYTON FUNDACJA
University of Crete
TNS OPINION SA
Investigators
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Principal Investigator: Constantine Vardavas, MD,RN,MPH,PHD European Network For Smoking and Tobacco Prevention
  Study Documents (Full-Text)

Documents provided by European Network For Smoking and Tobacco Prevention:
Additional Information:
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Responsible Party: European Network For Smoking and Tobacco Prevention
ClinicalTrials.gov Identifier: NCT02773836    
Other Study ID Numbers: 681109
First Posted: May 16, 2016    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Keywords provided by European Network For Smoking and Tobacco Prevention:
tobacco use
e-cigarettes
public policy
ITC
Additional relevant MeSH terms:
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Lung Diseases
Tobacco Use Disorder
Respiratory Tract Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders