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Trial record 1 of 5 for:    TackSHS
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The TackSHS Survey: a Pan-European Study on SHS

This study is currently recruiting participants.
Verified December 2016 by Mario Negri Institute for Pharmacological Research
Sponsor:
ClinicalTrials.gov Identifier:
NCT02928536
First Posted: October 10, 2016
Last Update Posted: December 2, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Institut Català d'Oncologia
European Commission
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research
  Purpose
Within the TackSHS project (H2020 project grant agreement No 681040), we will conduct a European cross-sectional study, aiming at i) estimating prevalence and investigating determinants of smoking, e-cigarette use and exposure to SHS and to e-cigarette aerosol; ii) analyzing the attitudes, perceptions and behaviours of the adult European population towards policies to limit SHS exposure; iii) comparing selected smoking-related data between TackSHS and a previously conducted pan-European survey; iv) assessing mortality and morbidity from selected respiratory and cardiovascular diseases attributable to SHS exposure among adults and children in Europe; v) quantifying the economic burden associated to the exposure to SHS and e-cigarette aerosol in Europe. Overall, approximately 12,000 individuals aged 15 years or over will be enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV, PL, PT, RO, UK). Surveys will be representative of the country-specific population in terms of sex, age, and socio-economic characteristics.

Condition Intervention
Second Hand Tobacco Smoke Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The TackSHS Survey: a Cross-sectional Study on Secondhand Smoke in 12 European Countries

Resource links provided by NLM:


Further study details as provided by Mario Negri Institute for Pharmacological Research:

Primary Outcome Measures:
  • Prevalence of exposure to SHS and to electronic cigarette aerosol assessed through self-reported information (questionnaire) [ Time Frame: Baseline ]
    Exposure to SHS and electronic cigarette aerosol is assessed at baseline (thus representing current exposure at interview) through questions on general exposure during a working day and during a non-working day


Secondary Outcome Measures:
  • Prevalence of current smokers and of electronic cigarette users [ Time Frame: Baseline ]
    Use of cigarettes and electronic cigarettes is assessed at baseline (thus representing current use at interview) through questions on lifetime use


Estimated Enrollment: 12000
Study Start Date: December 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: no intervention
    This is an observational study. No intervention is considered
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

In each of the 12 selected European countries, approximately 1000 individuals, representative of the general population aged 15 years and over in terms of age, sex, geographic area, and socio-economic characteristics, will be enrolled in this cross-sectional study. The final sample will therefore include a total of approximately 12,000 subjects.

Sample size computation The sample size in each specific country will allow us to obtain prevalence estimates with a maximum standard error (SE) lower than ± 1.6%. Therefore, with such a sample size we will be able to provide stable prevalence estimates (with a relatively small 95% confidence interval), overall but also in each specific country.

Criteria

Inclusion Criteria:

  • individuals aged 15 years and over;
  • individuals resident of the 12 selected countries;
  • individuals able to understand and answer the questions of the questionnaire of the study in the country-specific language;
  • individuals who formally accept to participate in the study.

Exclusion Criteria:

No specific exclusion criteria are considered.

  Contacts and Locations
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): NCT02928536


Contacts
Contact: Silvano Gallus, Sc.D. +39023901 ext 4657 silvano.gallus@marionegri.it
Contact: Alessandra Lugo, PhD +39023901 ext 4653 alessandra.lugo@marionegri.it

Locations
Italy
DOXA Institute Recruiting
Milan, Italy, 20144
Contact: Silvano Gallus, ScD    +39023901 ext 4657    silvano.gallus@marionegri.it   
Contact: Alessandra Lugo, PhD    +39023901 ext 4653    alessandra.lugo@marionegri.it   
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Institut Català d'Oncologia
European Commission
Investigators
Principal Investigator: Silvano Gallus, Sc.D Istituto Di Ricerche Farmacologiche Mario Negri
  More Information

Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT02928536     History of Changes
Other Study ID Numbers: 6895
First Submitted: October 4, 2016
First Posted: October 10, 2016
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan is made to share IPD. Main results (aggregated data) will be published in peer-reviewed open-access journals