NCT02773836

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,036

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 3, 2019

Completed
Last Updated

June 3, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

May 11, 2016

Results QC Date

April 28, 2017

Last Update Submit

February 19, 2019

Conditions

Tobacco Dependence

Keywords

tobacco usee-cigarettespublic policyITC

Outcome Measures

Primary Outcomes (9)

  • 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: 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 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: 1. 5 min or less 2. 6-30 min 3. 31-60 min 4. More than 60 min

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

    Baseline Pre-TPD

  • Number of Participants Who Have Ever Tried to Quit Smoking

    Have you ever tried to quit smoking? 1. Yes 2. No 8 Refused 9 Don't know

    Baseline Pre-TPD

  • Number of Participants Who Plan to Quit Smoking

    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

    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: 1. Never 2. Rarely 3. Sometimes 4. Often 5. Very often 8 Refused 9 Don't know

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

    Post-TPD

  • Number of Participants Who Have Ever Tried to Quit Smoking

    Have you ever tried to quit smoking? 1. Yes 2. No 8 Refused 9 Don't know

    Post-TPD

  • Number of Participants Who Plan to Quit Smoking

    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

    Post-TPD

Secondary Outcomes (4)

  • Number of Participants Who Think About The Money They Spend on Smoking

    Baseline Pre-TPD

  • Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People

    Baseline Pre-TPD

  • Number of Participants Who Think About The Money They Spend on Smoking

    Post-TPD

  • Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People

    Post-TPD

Study Arms (6)

Greek cohort

Participants recruited from Greece will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

German cohort

Participants recruited from Germany will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

Romanian Cohort

Participants recruited from Romania will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

Spanish Cohort

Participants recruited from Spain will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

Hungarian Cohort

Participants recruited from Hungary will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

Polish cohort

Participants recruited from Poland will receive a questionnaire at pre- and post- intervention

Other: Questionnaire

Interventions

QuestionnaireOTHER

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

German cohortGreek cohortHungarian CohortPolish cohortRomanian CohortSpanish Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Network For Smoking and Tobacco Prevention

Brussels, 1050, Belgium

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco UseVaping

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSmoking

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr Constantine Vardavas
Organization
European Network for Smoking and Tobacco Prevention
vardavas@tobcontrol.eu
+306937281680

Study Officials

  • Constantine Vardavas, MD,RN,MPH,PHD

    European Network For Smoking and Tobacco Prevention

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 16, 2016

Study Start

June 15, 2016

Primary Completion

September 12, 2016

Study Completion

May 6, 2018

Last Updated

June 3, 2019

Results First Posted

June 3, 2019

Record last verified: 2019-02

Locations

BE(1)