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The TackSHS Survey: a Pan-European Study on SHS

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ClinicalTrials.gov Identifier: NCT02928536
Recruitment Status : Completed
First Posted : October 10, 2016
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Institut Català d'Oncologia
European Commission
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief Summary:
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 or disease Intervention/treatment
Second Hand Tobacco Smoke Other: no intervention

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 11902 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The TackSHS Survey: a Cross-sectional Study on Secondhand Smoke in 12 European Countries
Actual Study Start Date : December 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes


Intervention Details:
  • Other: no intervention
    This is an observational study. No intervention is considered


Primary Outcome Measures :
  1. Prevalence of Daily Exposure to Secondhand Smoke (SHS) in Indoor Settings [ Time Frame: Baseline ]
    Exposure to secondhand smoke (SHS) is assessed among non-smokers and indicates the general daily exposure (during a working day and during a non-working day) to SHS in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHS exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).

  2. Prevalence of Exposure to Secondhand Aerosol (SHA) From Electronic Cigarettes [ Time Frame: Baseline ]
    Exposure to secondhand aerosol (SHA) is assessed among electronic cigarette non-users and indicates the general daily exposure (during a working day and during a non-working day) to SHA in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHA exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).


Secondary Outcome Measures :
  1. Prevalence of Never, Current and Former Smokers [ Time Frame: Baseline ]
    Cigarette consumption is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Never smokers were defined as participants who had never smoked or had smoked less than 100 cigarettes in their lifetime. Smokers were defined as participants who reported smoking at least 100 cigarettes (including hand-rolled cigarettes) during their lifetime. Current smokers were smokers who reported smoking at the time they participated in this survey, while former smokers were smokers who stopped smoking by the time they participated in this survey.

  2. Prevalence of Never, Current and Former Electronic Cigarette Users [ Time Frame: Baseline ]
    Electronic cigarette use is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Current electronic cigarette users were defined as those who reported using the electronic cigarette occasionally (5 days or less) or regularly (more than 5 days) in the last 30 days. Former users of electronic cigarette were those who reported using it in the part but not over the last 30 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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.


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


Locations
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Italy
DOXA Institute
Milan, Italy, 20144
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Institut Català d'Oncologia
European Commission
Investigators
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Principal Investigator: Silvano Gallus, Sc.D Istituto Di Ricerche Farmacologiche Mario Negri
  Study Documents (Full-Text)

Documents provided by Mario Negri Institute for Pharmacological Research:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT02928536    
Other Study ID Numbers: 6895
First Posted: October 10, 2016    Key Record Dates
Results First Posted: November 20, 2019
Last Update Posted: November 20, 2019
Last Verified: October 2019
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